Numerous clinical trials, ranging from early-phase through Phase 4 research, evaluate the safety and therapeutic utility of azithromycin across active, completed, and withdrawn protocols. Sponsored by university medical centers, hospital networks, and global philanthropic entities such as the Bill & Melinda Gates Foundation, these studies address diverse indications including genital tract infections, chronic lung disease, endometritis, and viral infections like COVID-19. Further research focuses on specific applications, such as early pathogen clearance in typhus fevers and adjunctive therapy for uncomplicated severe acute malnutrition.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06461429 | NOT_YET_RECRUITING | Preterm Birth |
University of Melbourne |
2025-11-01 | |
| NCT07485010 | NOT_YET_RECRUITING | Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease |
The University of Queensland |
2027-04 | PHASE2 |
| NCT07625228 | NOT_YET_RECRUITING | Rheumatic Fever; Valvular Heart Diseases; Valvular Cardiomyopathy |
Ladoke Akintola University of Technology, Ogbomoso, Nigeria |
2027-01-05 | |
| NCT05763693 | NOT_YET_RECRUITING | Neonatal Death; Infectious Disease; Nutritional Deficiency |
University of California, San Francisco |
2026-04 | PHASE4 |
| NCT06906757 | NOT_YET_RECRUITING | PPROM; Preterm |
University of Melbourne |
2025-09 | |
| NCT07052942 | RECRUITING | Asthma; Asthma Attack; Asthma Exacerbations |
DARTNet Institute |
2025-08-01 | PHASE4 |
| NCT06289647 | WITHDRAWN | Trachoma |
University of California, San Francisco |
2024-10 | PHASE4 |
| NCT07433426 | RECRUITING | Diarrhea Infectious; Shigella; Growth & Development |
Johns Hopkins Bloomberg School of Public Health |
2026-03-18 | PHASE2 |
| NCT07183462 | RECRUITING | Pregnancy Complications, Infectious; Premature Birth; Neonatal Diseases and Abnormalities; Antibiotic Prophylaxis; Latency Period; Prematurity |
Sheba Medical Center |
2025-09-10 | PHASE4 |
| NCT04310930 | RECRUITING | Pulmonary Disease Due to Mycobacteria (Diagnosis) |
The University of Queensland |
2020-03-02 | PHASE2; PHASE3 |
| NCT06349122 | NOT_YET_RECRUITING | Bacterial Vaginosis; Vaginal Dysbiosis; Premature Delivery |
Assistance Publique Hopitaux De Marseille |
2026-10 | PHASE3 |
| NCT07306234 | NOT_YET_RECRUITING | Mycoplasma Pneumoniae; Mycoplasma Pneumoniae Pneumonia |
Young June Choe |
2026-03-01 | PHASE4 |
| NCT06082037 | RECRUITING | Lung Transplant Rejection |
Sanofi |
2023-10-10 | PHASE3 |
| NCT04669717 | RECRUITING | Periodontal Diseases; Antibiotics; Pharmacokinetics |
University of Geneva, Switzerland |
2021-09-01 | PHASE4 |
| NCT06488781 | RECRUITING | Obesity in Pregnancy; Labor Complication |
University of Oklahoma |
2025-04-29 | PHASE2 |
| NCT06325293 | RECRUITING | Community Acquired Pneumonia in Children; Mycoplasma Pneumoniae; Mycoplasma Pneumoniae Pneumonia |
Christoph Berger |
2025-01-28 | |
| NCT05580666 | RECRUITING | HIV Disease Progression |
Population Health Research Institute |
2023-05-08 | PHASE3 |
| NCT04381936 | RECRUITING | Pneumonia |
University of Oxford |
2020-03-19 | PHASE3 |
| NCT07213765 | RECRUITING | Mycobacterium Avium Complex Pulmonary Disease |
Bin Cao |
2025-07-24 | PHASE4 |
| NCT06010719 | RECRUITING | Malnutrition, Child; Severe Acute Malnutrition |
University of California, San Francisco |
2024-10-23 | PHASE4 |
| NCT05772013 | RECRUITING | Chronic Obstructive Pulmonary Disease |
Dr Ian B Wilkinson |
2024-03-05 | PHASE4 |
| NCT07608562 | NOT_YET_RECRUITING | Cervical Insufficiency |
Wake Forest University Health Sciences |
2026-09 | PHASE4 |
| NCT07669207 | RECRUITING | Preterm Prelabor Rupture of Membranes; PPROM |
Alexa Henderson |
2026-08-19 | PHASE4 |
| NCT06358872 | RECRUITING | Mortality; Antimicrobial Resistance |
University of California, San Francisco |
2024-04-29 | PHASE4 |
| NCT03236987 | RECRUITING | Lung Infection; MAC Lung Disease |
Centre Hospitalier Universitaire, Amiens |
2018-02-05 | PHASE3 |
| NCT06605118 | RECRUITING | Obstetrical Complications; Labor and Delivery Complication; Cesarean Delivery |
The George Washington University Biostatistics Center |
2024-11-06 | PHASE3 |
| NCT05157685 | RECRUITING | Sinusitis, Chronic; Sinus Infection Chronic |
Centre Hospitalier Intercommunal Creteil |
2022-11-21 | PHASE3 |
| NCT01233297 | ACTIVE_NOT_RECRUITING | Childhood Asthma With Acute Exacerbation |
Copenhagen Studies on Asthma in Childhood |
2010-11 | PHASE2 |
| NCT05922761 | RECRUITING | Bronchiolitis Obliterans Syndrome; Bronchiolitis Obliterans; Lung Diseases; Chronic Graft Versus Host Disease |
Dana-Farber Cancer Institute |
2024-05-31 | PHASE2 |
| NCT07608328 | NOT_YET_RECRUITING | Non-cystic Fibrosis Bronchiectasis; Bronchiectasis Adult; Bronchiectasis; Bronchiectasis With Acute Exacerbation |
Assiut University |
2026-05-21 | PHASE4 |
| NCT07615842 | NOT_YET_RECRUITING | Antibiotic Resistance Prevention |
University of Virginia |
2026-06-01 | PHASE1 |
| NCT06409299 | NOT_YET_RECRUITING | Tracheomalacia; Bronchopulmonary Dysplasia (BPD); Vascular Ring; Cystic Lung Disease; Bronchiectasis; Chronic Atelectasis |
Rigshospitalet, Denmark |
2024-09-01 | PHASE3 |
| NCT03335072 | ACTIVE_NOT_RECRUITING | Trachoma |
University of California, San Francisco |
2022-02-07 | PHASE4 |
| NCT07795086 | NOT_YET_RECRUITING | Chronic Obstructive Pulmonary Disease With Exacerbation |
Sidra Aziz |
2027-02 | PHASE4 |
| NCT07314281 | RECRUITING | Enteric Fever |
Indus Hospital and Health Network |
2025-04-22 | PHASE4 |
| NCT07641348 | NOT_YET_RECRUITING | Typhoid Fever |
Iqra Asghar Ali |
2026-07-01 | |
| NCT05842681 | RECRUITING | Idiopathic Pulmonary Fibrosis |
Assiut University |
2023-06-01 | |
| NCT07713186 | NOT_YET_RECRUITING | Atopic Dermatitis |
Cairo University |
2026-08-01 | PHASE4 |
| NCT03250975 | ACTIVE_NOT_RECRUITING | Intubation Complication |
Vanderbilt University Medical Center |
2017-08-19 | PHASE1; PHASE2 |
| NCT05847322 | RECRUITING | Healthy Volunteer Study |
University of Southampton |
2022-12-06 | |
| NCT05028153 | RECRUITING | Childhood Asthma With Acute Exacerbation |
Copenhagen Studies on Asthma in Childhood |
2022-11-14 | PHASE2 |
| NCT03083197 | ACTIVE_NOT_RECRUITING | Scrub Typhus |
University of Oxford |
2017-10-15 | PHASE4 |
| NCT05949190 | ACTIVE_NOT_RECRUITING | Malnutrition in Pregnancy; Preterm Birth; Child Development; Postpartum Depression; Antepartum Depression |
Washington University School of Medicine |
2023-08-18 | |
| NCT06543290 | RECRUITING | Infections |
Arrowhead Regional Medical Center |
2023-08-07 | PHASE1 |
| NCT05994742 | COMPLETED | Severe Acute Malnutrition; HIV; Comorbidities and Coexisting Conditions; Child Malnutrition |
Queen Mary University of London |
2024-07-15 | PHASE3 |
| NCT06273891 | ACTIVE_NOT_RECRUITING | Premature Rupture of Membrane |
Inova Health Care Services |
2024-03-08 | PHASE3 |
| NCT06618534 | COMPLETED | Meningococcal Infections |
Emory University |
2024-11-12 | PHASE2 |
| NCT05961189 | COMPLETED | Gastrointestinal Microbiome; Exercise |
Rutgers, The State University of New Jersey |
2023-09-01 | EARLY_PHASE1 |
| NCT07384793 | ACTIVE_NOT_RECRUITING | Acne Vulgaris II or III Degree |
Hayatabad Medical Complex |
2025-10-12 | PHASE4 |
| NCT03523156 | WITHDRAWN | Trachoma |
Emory University |
2025-06 | PHASE4 |
| NCT07777952 | COMPLETED | Acne Vulgaris |
Mahmoud Rageh |
2025-10-12 | |
| NCT04069312 | COMPLETED | Chronic Obstructive Pulmonary Disease Severe; Chronic Bronchitis |
Johns Hopkins University |
2020-02-11 | PHASE3 |
| NCT04339270 | UNKNOWN | Chronic Obstructive Pulmonary Disease |
University Hospital, Montpellier |
2023-02-03 | PHASE4 |
| NCT06715150 | NOT_YET_RECRUITING | Peri-implantitis |
University of Santiago de Compostela |
2025-01-10 | PHASE4 |
| NCT03672630 | COMPLETED | Mycobacterium Avium Complex; Nontuberculous Mycobacterium Infection |
Kevin Winthrop |
2019-02-22 | PHASE2; PHASE3 |
| NCT06170983 | UNKNOWN | Skin Infection |
Medical University of Vienna |
2024-01-01 | |
| NCT05398055 | UNKNOWN | Rocky Mountain Spotted Fever |
Hospital General de Mexicali |
2022-05-12 | PHASE3 |
| NCT04921943 | RECRUITING | Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterium Infection |
Oregon Health and Science University |
2021-05-18 | PHASE4 |
| NCT04349826 | COMPLETED | Typhoid Fever |
Oxford University Clinical Research Unit, Vietnam |
2021-05-23 | PHASE4 |
| NCT05337566 | RECRUITING | Infection Post Op; Hysterectomy; Antibiotics; Prophylactic |
Helsinki University Central Hospital |
2022-09-05 | |
| NCT07445282 | COMPLETED | Extensively Drug-Resistant Typhoid Fever; Typhoid Fever; Salmonella Typhi Infection |
Sheikh Zayed Medical College |
2025-05-14 | PHASE4 |
| NCT04235816 | ACTIVE_NOT_RECRUITING | Child Mortality |
Barcelona Institute for Global Health |
2021-03-15 | PHASE3 |
| NCT05677282 | RECRUITING | Diarrhoea;Acute; Diarrhea Travelers |
Henry M. Jackson Foundation for the Advancement of Military Medicine |
2022-10-28 | PHASE4 |
| NCT05972772 | RECRUITING | Infectious Disease; Therapeutics |
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit |
2024-11-01 | PHASE2; PHASE3 |
| NCT06958146 | NOT_YET_RECRUITING | Maternal and Neonatal Sepsis; Intrapartum Antibiotics |
Armed Forces Hospital, Pakistan |
2025-05-01 | PHASE4 |
| NCT06077916 | COMPLETED | Upper Gastrointestinal Bleeding |
Clinical Hospital Colentina |
2023-10-01 | |
| NCT07320612 | COMPLETED | Nephrotic Syndrome |
University of Child Health Sciences and Children's Hospital, Lahore |
2025-03-08 | PHASE1 |
| NCT07148622 | COMPLETED | Preterm Premature Rupture of Membranes (PPROM); Prophylaxis; Perinatal Outcomes |
Yuzuncu Yil University |
2024-10-01 | |
| NCT06584474 | COMPLETED | Bronchopulmonary Dysplasia; Premature; Ventilation, Mechanical |
Alexandria University |
2024-10-02 | PHASE4 |
| NCT04326478 | COMPLETED | Cholera |
Massachusetts General Hospital |
2021-10-31 | PHASE2 |
| NCT05328817 | UNKNOWN | Preterm Premature Rupture of Membrane |
Eastern Virginia Medical School |
2022-05-01 | |
| NCT07394725 | COMPLETED | Pre-term Premature Rupture of Membranes |
District Headquarters Teaching Hospital Sahiwal |
2024-04-01 | PHASE1 |
| NCT05121974 | COMPLETED | Shigellosis |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2022-08-18 | PHASE2 |
| NCT03909737 | ACTIVE_NOT_RECRUITING | Stillbirths and Infant Mortality |
University of Maryland, Baltimore |
2020-09-24 | PHASE4 |
| NCT04716712 | ACTIVE_NOT_RECRUITING | Child Mortality |
University of California, San Francisco |
2021-10-04 | PHASE4 |
| NCT02754583 | COMPLETED | Trachoma |
University of California, San Francisco |
2015-12-05 | PHASE3 |
| NCT04424511 | COMPLETED | Mortality |
Tampere University |
2020-10-15 | PHASE3 |
| NCT04185402 | COMPLETED | Trachoma |
University of California, San Francisco |
2021-05-29 | PHASE4 |
| NCT04669288 | TERMINATED | Asthma; Wheezing |
University of Arizona |
2021-11-22 | PHASE3 |
| NCT05132829 | UNKNOWN | Preterm Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Physiological Effects of Drugs; Uterine Cervical Incompetence; Anti-Bacterial Agents; Azithromycin; Cefazolin |
Thomas Jefferson University |
2021-12-20 | PHASE4 |
| NCT04481555 | COMPLETED | COPD; Inhaled Corticosteroid; Azithromycin; COPD Exacerbation; Pneumonia |
Chronic Obstructive Pulmonary Disease Trial Network, Denmark |
2021-06-28 | PHASE4 |
| NCT06272370 | COMPLETED | Asthma; Bronchial Diseases; Respiratory Tract Infections; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Immune System Diseases |
DARTNet Institute |
2024-02-01 | PHASE4 |
| NCT04224987 | COMPLETED | Mortality; Resistance Bacterial; Child, Only |
University of California, San Francisco |
2020-11-24 | PHASE4 |
| NCT05016895 | COMPLETED | Child Mortality |
FHI 360 |
2021-08-27 | |
| NCT04294641 | COMPLETED | Chronic GVHD |
National Cancer Institute (NCI) |
2021-05-10 | PHASE2 |
| NCT05764876 | COMPLETED | Yaws; Cutaneous Ulcer |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2023-03-14 | PHASE3 |
| NCT07064278 | COMPLETED | Refractory Mycoplasma Pneumoniae Pneumonia |
Children's Hospital of Hebei Province |
2022-12-01 | |
| NCT05596721 | UNKNOWN | Asthma; Chest Syndrome; Azithromycin; Effect of Drug |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2023-01-01 | PHASE4 |
| NCT03862495 | COMPLETED | Chlamydia Trachomatis Infection |
University of North Carolina, Chapel Hill |
2020-05-21 | |
| NCT05972772 | Not yet recruiting | Infectious Disease|Therapeutics |
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit|Mahidol Oxford Tropical Medicine Research Unit |
2024-03-20 | Phase 2|Phase 3 |
| NCT05345457 | TERMINATED | Pregnancy Preterm; Pregnancy Prom; PROM, Preterm (Pregnancy); PROM (Pregnancy); Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor; Premature Birth |
University Hospitals Cleveland Medical Center |
2023-01-13 | PHASE4 |
| NCT05966688 | COMPLETED | Healthy Volunteers |
Spero Therapeutics |
2023-08-04 | PHASE1 |
| NCT05288023 | TERMINATED | Resistance Bacterial; Morality; Child Health; Implementation |
University of California, San Francisco |
2022-12-01 | PHASE4 |
| NCT04186247 | TERMINATED | Crohn Disease; Pediatric Crohns Disease |
University of North Carolina, Chapel Hill |
2021-08-13 | PHASE2 |
| NCT03060473 | TERMINATED | Preterm Premature Rupture of Membranes (PPROM) |
The University of Texas Medical Branch, Galveston |
2017-02-23 | PHASE3 |
| NCT03676764 | COMPLETED | Childhood Mortality |
University of California, San Francisco |
2019-08-01 | PHASE4 |
| NCT04280406 | UNKNOWN | Dental Implant Failed |
Université de Montréal |
2020-02-25 | PHASE1 |
| NCT05473234 | TERMINATED | Severe Acute Malnutrition |
University of California, San Francisco |
2022-10-06 | PHASE3 |
| NCT04198649 | TERMINATED | Severe Chronic Periodontitis |
University Hospital, Strasbourg, France |
2021-11-02 | PHASE3 |
| NCT04010539 | COMPLETED | Gonorrhea |
GlaxoSmithKline |
2019-10-21 | PHASE3 |
| NCT05971654 | UNKNOWN | Preterm Labor |
Beni-Suef University |
2023-07-30 | PHASE2; PHASE3 |
| NCT05634759 | COMPLETED | Trachoma |
Emory University |
2022-05-04 | PHASE4 |
| NCT04774991 | COMPLETED | Mortality; Child Health; Implementation |
University of California, San Francisco |
2021-06-28 | PHASE4 |
| NCT04353661 | TERMINATED | Chronic Obstructive Pulmonary Disease |
Genentech, Inc. |
2021-11-16 | PHASE2 |
| NCT04677543 | COMPLETED | Mycobacterium Infections, Nontuberculous |
Insmed Incorporated |
2020-12-22 | PHASE3 |
| NCT06149117 | COMPLETED | Upper Respiratory Tract Infection; Lower Respiratory Infection; Skin Infection; Subcutaneous Tissues Infection; Genital Infection |
Peking University People's Hospital |
2022-11-16 | PHASE4 |
| NCT05796362 | Not yet recruiting | Infectious Disease|Drug Effect|Clinical Infection |
Brigham and Women''s Hospital|Bill and Melinda Gates Foundation |
2023-04 | Phase 1 |
| NCT06199440 | COMPLETED | Periodontal Diseases; Type 2 Diabetes |
King Abdulaziz University |
2022-06-01 | PHASE1; PHASE2 |
| NCT03911440 | UNKNOWN | Atypical Pneumonia |
National Taiwan University Hospital |
2018-11-10 | |
| NCT03871491 | COMPLETED | Maternal Death; Maternal Infections Affecting Fetus or Newborn; Neonatal SEPSIS; Maternal Sepsis During Labor; Neonatal Death; Postpartum Sepsis |
NICHD Global Network for Women's and Children's Health |
2020-09-01 | PHASE3 |
| NCT03162497 | COMPLETED | Dry Eye Syndromes; Meibomian Gland Dysfunction |
Medical University of Vienna |
2018-01-08 | PHASE4 |
| NCT04012177 | UNKNOWN | Undernutrition |
Vital Pakistan Trust |
2019-07-22 | |
| NCT05437783 | UNKNOWN | Comparative Bioavailability Study |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2020-01-01 | PHASE1 |
| NCT05629468 | COMPLETED | Acne Vulgaris |
Pak Emirates Military Hospital |
2021-10-15 | PHASE3 |
| NCT06090565 | COMPLETED | Gonorrhea |
Bulovka Hospital |
2021-04-01 | PHASE4 |
| NCT03925480 | COMPLETED | Bacterial Infections |
Murdoch Childrens Research Institute |
2019-07-01 | PHASE3 |
| NCT03160638 | COMPLETED | Tuberculosis, Pulmonary |
University Medical Center Groningen |
2018-02-01 | PHASE2 |
| NCT05027516 | COMPLETED | Neisseria Gonorrhoeae |
Institute of Tropical Medicine, Belgium |
2022-01-17 | PHASE4 |
| NCT03682653 | COMPLETED | Childhood Mortality |
University of California, San Francisco |
2019-04-11 | PHASE4 |
| NCT04359953 | TERMINATED | COVID-19 Infection |
University Hospital, Strasbourg, France |
2020-04-25 | PHASE3 |
| NCT04341207 | UNKNOWN | Cancer & COVID 19 |
Gustave Roussy, Cancer Campus, Grand Paris |
2020-04-03 | PHASE2 |
| NCT04319705 | UNKNOWN | Asthma; COPD; Exacerbation Copd; Asthma; Eosinophilic; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Immune System Diseases |
Bispebjerg Hospital |
2020-03-02 | PHASE4 |
| NCT04390152 | TERMINATED | Acute Respiratory Distress Syndrome |
BioXcellerator |
2020-01-13 | PHASE1; PHASE2 |
| NCT05311228 | COMPLETED | Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Necrotizing Enterocolitis |
Indonesia University |
2021-06-08 | PHASE4 |
| NCT03570814 | COMPLETED | Trachoma; Lymphatic Filariases |
London School of Hygiene and Tropical Medicine |
2021-12-01 | PHASE4 |
| NCT04454151 | UNKNOWN | Familial Adenomatous Polyposis |
Tel-Aviv Sourasky Medical Center |
2020-08-01 | PHASE4 |
| NCT03530319 | UNKNOWN | Pneumonia, Mycoplasma |
National Taiwan University Hospital |
2018-11-10 | |
| NCT04590274 | WITHDRAWN | Covid19; SARS (Severe Acute Respiratory Syndrome) |
International Brain Research Foundation |
2020-11 | PHASE1 |
| NCT04613271 | COMPLETED | Infectious Disease; SARS-CoV Infection; Covid19 |
Ina-Respond |
2020-10-15 | PHASE3 |
| NCT04954040 | UNKNOWN | Acute Respiratory Distress Syndrome; Covid19 |
Maimónides Biomedical Research Institute of Córdoba |
2021-02-10 | PHASE2 |
| NCT04395768 | UNKNOWN | COVID19 |
National Institute of Integrative Medicine, Australia |
2020-09-09 | PHASE2 |
| NCT04380818 | UNKNOWN | Pneumonia, Viral |
Grupo de Investigación Clínica en Oncología Radioterapia |
2020-06-05 | |
| NCT05026801 | WITHDRAWN | Respiratory Tract Infection Viral |
Iterum Therapeutics, International Limited |
2021-02-08 | PHASE3 |
| NCT03090048 | UNKNOWN | Acne Vulgaris |
Manchanda Medical Clinic |
2021-04-01 | EARLY_PHASE1 |
| NCT04296383 | UNKNOWN | Mycoplasma Pneumoniae Pneumonia |
Jiangxi Qingfeng Pharmaceutical Co. Ltd. |
2020-06-15 | |
| NCT04964583 | UNKNOWN | Covid19 |
Coordinación de Investigación en Salud, Mexico |
2021-01-20 | PHASE2; PHASE3 |
| NCT03953118 | TERMINATED | Dry Eye; Neuropathic Eye Pain; Ocular Microbiome; Depression, Anxiety |
University of California, San Francisco |
2019-09-01 | PHASE4 |
| NCT04459702 | WITHDRAWN | COVID; COVID-19; Corona Virus Infection; Coronavirus Infection; Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere; Coronavirus-19; SARS-CoV 2; SARS Pneumonia |
ProgenaBiome |
2020-07 | PHASE2 |
| NCT04369365 | COMPLETED | COVID |
Prof. Dr. Matthias Preusser |
2020-04-27 | PHASE2 |
| NCT04332094 | UNKNOWN | COVID-19 |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
2020-04-02 | PHASE2 |
| NCT03840057 | UNKNOWN | Gastro Intestinal Bleeding; Upper Gastrointestinal Bleeding |
Waihong Chung |
2020-07-01 | PHASE2 |
| NCT05118984 | COMPLETED | Meconium Stained; Azithromycin; Postpartum Endometritis |
Cairo University |
2021-02-16 | PHASE4 |
| NCT03199547 | COMPLETED | Neonatal SEPSIS |
London School of Hygiene and Tropical Medicine |
2017-10-21 | PHASE3 |
| NCT04715295 | UNKNOWN | COVID-19 |
Yaounde Central Hospital |
2020-10-05 | PHASE4 |
| NCT04171388 | WITHDRAWN | Low Birthweight; Preterm Birth; Maternal; Malnutrition, Affecting Fetus; Sexually Transmitted Diseases; Urinary Tract Infections; Pregnancy and Infectious Disease |
Brigham and Women's Hospital |
2020-03-01 | PHASE4 |
| NCT04344444 | TERMINATED | COVID-19 |
LCMC Health |
2020-04-13 | PHASE3 |
| NCT04341727 | TERMINATED | Coronavirus Infection |
Washington University School of Medicine |
2020-04-04 | PHASE3 |
| NCT02336516 | COMPLETED | Haemolytic and Uremic Syndrome |
Assistance Publique - Hôpitaux de Paris |
2015-07 | |
| NCT02911935 | COMPLETED | Respiratory Syncytial Virus, Bronchiolitis |
Washington University School of Medicine |
2016-11 | PHASE2; PHASE3 |
| NCT04332107 | TERMINATED | COVID-19; SARS-CoV-2 |
Thomas M. Lietman |
2020-05-22 | PHASE3 |
| NCT03736629 | TERMINATED | Asthma Chronic |
University of Chicago |
2019-02-01 | PHASE2 |
| NCT04363203 | SUSPENDED | SARS-CoV-2; COVID-19 |
Salomeh Keyhani MD |
2020-04-30 | PHASE3 |
| NCT04673214 | COMPLETED | Covid19 |
Gilberto Cruz Arteaga |
2020-12-16 | PHASE3 |
| NCT04345861 | TERMINATED | Coronavirus Infection; Pneumonia, Viral |
University Hospital, Montpellier |
2020-04-11 | PHASE2; PHASE3 |
| NCT03854929 | COMPLETED | Dysentery, Shigella; Shigellosis; Diarrhea |
Oxford University Clinical Research Unit, Vietnam |
2019-12-11 | PHASE4 |
| NCT03751514 | UNKNOWN | Whooping Cough |
University of Southampton |
2017-05-22 | |
| NCT04322396 | TERMINATED | Virus Diseases; Infection Viral; Corona Virus Infection |
Chronic Obstructive Pulmonary Disease Trial Network, Denmark |
2020-04-06 | PHASE2 |
| NCT04617626 | COMPLETED | Child Mortality; Azithromycin |
FHI 360 |
2020-11-20 | |
| NCT04381962 | COMPLETED | COVID-19 |
University of Oxford |
2020-06-03 | PHASE3 |
| NCT03431168 | COMPLETED | HIV; Pregnancy Malaria; Sexually Transmitted Infection |
University of Alabama at Birmingham |
2018-03-07 | PHASE2 |
| NCT04202380 | COMPLETED | Preterm Pre-labor Rupture of Membranes |
Assiut University |
2020-01-01 | |
| NCT04334382 | UNKNOWN | COVID-19 |
Intermountain Health Care, Inc. |
2020-04-02 | PHASE3 |
| NCT04365582 | WITHDRAWN | COVID |
Fondation Hôpital Saint-Joseph |
2020-05-07 | PHASE3 |
| NCT04394182 | SUSPENDED | Pneumonia, Viral; Cytokine Storm |
Fundacion GenesisCare |
2020-04-21 | |
| NCT04411433 | UNKNOWN | Sars-CoV2; COVID-19 |
Ministry of Health, Turkey |
2020-05-08 | PHASE3 |
| NCT04154722 | COMPLETED | Typhoid Fever |
Ziauddin University |
2019-06-20 | PHASE4 |
| NCT04294069 | COMPLETED | Preterm Premature Rupture of Membrane |
Thomas Jefferson University |
2020-09-14 | PHASE4 |
| NCT03568643 | COMPLETED | Uncomplicated Severe Acute Malnutrition |
University of California, San Francisco |
2020-06-03 | PHASE3 |
| NCT04405921 | UNKNOWN | SARS-CoV-2 Pneumonia; COVID-19 |
Centre Hôpital Universitaire Farhat Hached |
2020-07 | PHASE3 |
| NCT03618108 | TERMINATED | Coronary Heart Disease; Chlamydophila Pneumoniae Infections |
Cadrock Pty. Ltd. |
2018-04-04 | PHASE2 |
| NCT03564652 | COMPLETED | Undernutrition |
Vital Pakistan Trust |
2018-08-01 | |
| NCT04338698 | COMPLETED | COVID 19 |
Shehnoor Azhar |
2020-04-22 | PHASE3 |
| NCT04361461 | WITHDRAWN | Coronavirus Infections; SARS-CoV 2; SARS (Severe Acute Respiratory Syndrome); Pulmonary Disease |
Apsen Farmaceutica S.A. |
2020-04-30 | PHASE3 |
| NCT04354428 | TERMINATED | COVID-19; SARS-CoV-2 |
University of Washington |
2020-04-16 | PHASE2; PHASE3 |
| NCT04347031 | COMPLETED | Pneumonia, Viral; Respiratory Failure |
Burnasyan Federal Medical Biophysical Center |
2020-04-08 | PHASE2; PHASE3 |
| NCT04374552 | WITHDRAWN | SARS-CoV-2 Infection |
Rutgers, The State University of New Jersey |
2020-05-05 | PHASE2 |
| NCT04336332 | TERMINATED | SARS-CoV-2; COVID-19 |
Rutgers, The State University of New Jersey |
2020-04-01 | PHASE2 |
| NCT04355052 | UNKNOWN | COVID - 19 |
Sheba Medical Center |
2020-04-11 | PHASE3 |
| NCT04370782 | COMPLETED | COVID-19 |
St. Francis Hospital, New York |
2020-04-28 | PHASE4 |
| NCT04729491 | COMPLETED | Covid19 |
Corpometria Institute |
2020-06-30 | PHASE2; PHASE3 |
| NCT04349410 | COMPLETED | CoVid 19 Positive |
The Camelot Foundation |
2020-04-11 | PHASE2; PHASE3 |
| NCT04392128 | WITHDRAWN | COVID19; Hematologic Malignancy |
Institut de cancérologie Strasbourg Europe |
2020-09-02 | PHASE2 |
| NCT04575558 | WITHDRAWN | Sars-CoV2 |
Latin American Cooperative Oncology Group |
2020-06-30 | PHASE2 |
| NCT04501965 | UNKNOWN | Covid19 |
Institute for Research and Development of Medicinal and Food Plants of Guinea |
2020-06-01 | PHASE2 |
| NCT04383717 | UNKNOWN | Respiratory Tract Infections |
Cairo University |
2020-05-05 | PHASE3 |
| NCT02048007 | COMPLETED | Childhood Mortality |
University of California, San Francisco |
2014-11 | PHASE4 |
| NCT03532464 | COMPLETED | Chlamydia Trachomatis Infection; Vaginal Infection; Anal Infection |
University Hospital, Bordeaux |
2018-10-10 | PHASE4 |
| NCT04354597 | WITHDRAWN | COVID-19 |
King Hussein Cancer Center |
2020-05-01 | |
| NCT04349592 | COMPLETED | Covid19 |
Hamad Medical Corporation |
2020-04-14 | |
| NCT04457609 | UNKNOWN | COVID; Pulmonary Infection; Sars-CoV2 |
Indonesia University |
2020-07 | PHASE1 |
| NCT04371406 | WITHDRAWN | Covid-19 |
Assistance Publique - Hôpitaux de Paris |
2020-04 | PHASE3 |
| NCT03338244 | COMPLETED | Childhood Mortality |
University of California, San Francisco |
2017-10-20 | PHASE4 |
| NCT04160026 | COMPLETED | Malaria in Pregnancy; Adherence, Treatment |
Liverpool School of Tropical Medicine |
2019-11-11 | PHASE4 |
| NCT04622891 | COMPLETED | Covid19 |
South Valley University |
2020-04-01 | |
| NCT04363060 | UNKNOWN | COVID-19 Pneumonia |
Nantes University Hospital |
2020-04-30 | PHASE3 |
| NCT04358081 | COMPLETED | Covid-19 |
Novartis Pharmaceuticals |
2020-05-01 | PHASE3 |
| NCT04528927 | WITHDRAWN | COVID 19; Patients Hospitalized |
Abderrahmane Mami Hospital |
2020-05-15 | PHASE3 |
| NCT04351919 | WITHDRAWN | Patients With COVID19 |
Abderrahmane Mami Hospital |
2020-05-05 | PHASE4 |
| NCT04358068 | TERMINATED | COVID-19; SARS-CoV 2 |
National Institute of Allergy and Infectious Diseases (NIAID) |
2020-05-13 | PHASE2 |
| NCT03676751 | COMPLETED | Child Growth; Diversity of Microbiome; Child Mortality; Resistance Bacterial |
University of California, San Francisco |
2019-10-10 | PHASE4 |
| NCT04329832 | COMPLETED | COVID-19 |
Intermountain Health Care, Inc. |
2020-03-30 | PHASE2 |
| NCT04348474 | SUSPENDED | Covid-19 |
Azidus Brasil |
2020-04-20 | EARLY_PHASE1 |
| NCT04020380 | COMPLETED | Sarcoidosis, Pulmonary |
Hull University Teaching Hospitals NHS Trust |
2019-09-06 | PHASE2 |
| NCT04344379 | COMPLETED | SARS-CoV-2 Infection |
Assistance Publique - Hôpitaux de Paris |
2020-04-17 | PHASE3 |
| NCT04335552 | TERMINATED | SARS-CoV-2 |
Duke University |
2020-04-17 | PHASE2 |
| NCT04321278 | COMPLETED | Coronavirus Infections; Pneumonia, Viral |
Hospital Israelita Albert Einstein |
2020-03-28 | PHASE3 |
| NCT04322123 | COMPLETED | Coronavirus Infections |
Hospital do Coracao |
2020-04-01 | PHASE3 |
| NCT04347512 | WITHDRAWN | Sars-CoV-2, Community-Acquired Pneumonia,COVID-19 |
University Hospital, Strasbourg, France |
2020-06-02 | PHASE3 |
| NCT03165123 | UNKNOWN | Post-operative Nausea and Vomiting |
Assiut University |
2019-06-01 | PHASE4 |
| NCT04371107 | SUSPENDED | Covid19; Azithromycin; Ambulatory |
Centre Hospitalier Universitaire, Amiens |
2020-04-29 | PHASE3 |
| NCT04365231 | WITHDRAWN | COVID19 |
Hospital St. Joseph, Marseille, France |
2020-04-01 | PHASE3 |
| NCT03831269 | UNKNOWN | Pityriasis Lichenoides |
Cairo University |
2019-02 | |
| NCT04329572 | SUSPENDED | COVID-19 |
Azidus Brasil |
2020-04-23 | EARLY_PHASE1 |
| NCT04328272 | UNKNOWN | COVID19 |
Prof. Dr. Umar Farooq |
2020-03-28 | PHASE3 |
| NCT04399746 | COMPLETED | COVID |
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado |
2020-03-15 | |
| NCT03248297 | COMPLETED | Postpartum Sepsis; Postpartum Endometritis; Postpartum Fever |
University of Alabama at Birmingham |
2018-01-12 | PHASE4 |
| NCT04341870 | SUSPENDED | COVID19; SARS-CoV-2 Infection |
Assistance Publique - Hôpitaux de Paris |
2020-04-11 | PHASE2; PHASE3 |
| NCT02414399 | UNKNOWN | Pneumonia; Diarrhea; Malaria; Co-infection; Death; Malnutrition |
University of Washington |
2016-06-28 | PHASE4 |
| NCT04359316 | UNKNOWN | COVID-19 |
Shahid Beheshti University of Medical Sciences |
2020-04-20 | PHASE4 |
| NCT03490123 | COMPLETED | Yaws |
Lihir Medical Centre |
2018-04-16 | PHASE4 |
| NCT03341273 | TERMINATED | Lower Respiratory Tract Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2017-12-08 | |
| NCT03683667 | COMPLETED | Stunting; Malnutrition; Protein; Enteric Pathogens; Campylobacter Infections |
Johns Hopkins Bloomberg School of Public Health |
2018-09-23 | PHASE2; PHASE3 |
| NCT03208179 | COMPLETED | Pregnancy; Malaria in Pregnancy; Malaria |
Liverpool School of Tropical Medicine |
2018-03-29 | PHASE3 |
| NCT03545373 | COMPLETED | Tuberculosis; Respiratory Tract Infections; Pneumonia |
London School of Hygiene and Tropical Medicine |
2019-02-25 | PHASE3 |
| NCT01270074 | COMPLETED | Cystic Fibrosis; Bronchiectasis |
The University of Queensland |
2012-04 | PHASE3 |
| NCT03268902 | COMPLETED | Malnutrition; Stunting; Cognitive Development; Enteric Pathogens |
Haydom Lutheran Hospital |
2017-09-05 | PHASE2; PHASE3 |
| NCT04278937 | COMPLETED | Preterm Birth |
Ain Shams Maternity Hospital |
2019-04-15 | PHASE4 |
| NCT02677701 | COMPLETED | Cystic Fibrosis |
Seattle Children's Hospital |
2016-10-21 | PHASE4 |
| NCT03130114 | COMPLETED | Diarrhea |
World Health Organization |
2017-05-13 | PHASE3 |
| NCT03944317 | UNKNOWN | Malaria in Pregnancy; Pregnancy |
Federal Medical Centre, Owo |
2019-06-01 | |
| NCT04179461 | COMPLETED | Asthma in Children |
Children's Hospital Medical Center, Cincinnati |
2018-03-16 | PHASE2 |
| NCT03960970 | UNKNOWN | Endometritis; Cesarean Section; Infection; Wound Infection |
RWJ Barnabas Health at Jersey City Medical Center |
2019-09-15 | PHASE2 |
| NCT03079388 | COMPLETED | Pregnancy; Malnutrition in Pregnancy; Nutrition Disorders; Stunting |
Washington University School of Medicine |
2017-02-27 | |
| NCT02173145 | COMPLETED | Idiopathic Pulmonary Fibrosis; Cough |
Insel Gruppe AG, University Hospital Bern |
2014-08-19 | |
| NCT04062175 | COMPLETED | Wound Sepsis |
Ain Shams University |
2019-03-20 | PHASE4 |
| NCT02024555 | COMPLETED | Sarcoidosis; Antimycobacterial Therapy |
Vanderbilt University |
2014-03 | PHASE2 |
| NCT03578679 | COMPLETED | Pediculoses |
Institut de Recherche pour le Developpement |
2018-07-11 | |
| NCT02913118 | UNKNOWN | Community Acquired Pneumonia |
Qingfeng Pharmaceutical Group |
2016-07 | PHASE4 |
| NCT02972957 | COMPLETED | Influenza |
London School of Hygiene and Tropical Medicine |
2017-01-30 | PHASE4 |
| NCT03676140 | COMPLETED | Trachoma; Yaws; Lymphatic Filariases; Scabies; Strongyloidiasis |
Lihir Medical Centre |
2018-10-01 | PHASE3 |
| NCT01224977 | UNKNOWN | Asthmatic Patients |
Universitaire Ziekenhuizen KU Leuven |
2011-07 | |
| NCT03045198 | UNKNOWN | Cystic Fibrosis |
University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn) |
2012-03 | PHASE4 |
| NCT02557958 | COMPLETED | Chronic Obstructive Pulmonary Disease |
NYU Langone Health |
2009-01 | EARLY_PHASE1 |
| NCT03664063 | COMPLETED | Lymphatic Filariasis; Yaws; Trauma |
Lihir Medical Centre |
2018-09-01 | PHASE2 |
| NCT02960503 | WITHDRAWN | Sickle Cell Disease |
Vanderbilt University |
2016-09 | PHASE1; PHASE2 |
| NCT02047981 | COMPLETED | Childhood Mortality |
University of California, San Francisco |
2014-12 | PHASE4 |
| NCT02426112 | COMPLETED | Chronic Lung Disease; HIV Infection |
London School of Hygiene and Tropical Medicine |
2016-06 | PHASE3 |
| NCT02054156 | COMPLETED | Cystic Fibrosis |
Bonnie Ramsey |
2014-06 | PHASE3 |
| NCT03233880 | UNKNOWN | Pre-Eclampsia |
Ain Shams Maternity Hospital |
2016-07-01 | PHASE4 |
| NCT03502356 | UNKNOWN | Randomized Controll Trial |
Ain Shams University |
2018-04-20 | PHASE1; PHASE2 |
| NCT02003911 | TERMINATED | Asthma |
Montefiore Medical Center |
2013-10 | PHASE4 |
| NCT02205255 | COMPLETED | Chronic Obstructive Pulmonary Disease |
Wim Janssens |
2014-08-01 | PHASE3 |
| NCT03353480 | COMPLETED | Bioequivalence |
Pfizer |
2017-12-20 | PHASE1 |
| NCT02211729 | COMPLETED | Malaria; Respiratory Infections |
London School of Hygiene and Tropical Medicine |
2014-05 | PHASE3 |
| NCT02630394 | WITHDRAWN | Sickle Cell Disease; Acute Chest Syndrome |
University of Mississippi Medical Center |
2015-09 | PHASE1 |
| NCT03273296 | COMPLETED | Microbial Colonization |
Finnish Institute for Health and Welfare |
2017-10-15 | PHASE4 |
| NCT02830230 | UNKNOWN | Cervical Inflammation and Human Papilloma Virus Performance |
Tata Memorial Hospital |
2016-07 | |
| NCT03252067 | UNKNOWN | Pharmacokinetics |
Beijing Tongren Hospital |
2017-08-02 | PHASE1 |
| NCT03235141 | UNKNOWN | Bacterial Conjunctivitis |
Beijing Tongren Hospital |
2017-07-07 | PHASE1 |
| NCT02135354 | TERMINATED | Chronic Obstructive Pulmonary Disease |
Wim Janssens |
2014-08-01 | PHASE3 |
| NCT03187834 | COMPLETED | Child Development |
University of California, San Francisco |
2017-07-04 | PHASE4 |
| NCT02307825 | COMPLETED | Chronic Rhinosinusitis; High-risk Patient |
Centre hospitalier de l'Université de Montréal (CHUM) |
2014-11 | PHASE4 |
| NCT02756403 | COMPLETED | First Trimester Abortion |
Medstar Health Research Institute |
2016-03 | |
| NCT01955252 | COMPLETED | Yaws |
Lihir Medical Centre |
2013-03 | PHASE3 |
| NCT01959100 | UNKNOWN | Malignant Hematological Diseases |
Assistance Publique - Hôpitaux de Paris |
2014-02 | PHASE3 |
| NCT02544984 | COMPLETED | Chronic Lung Disease |
The University of Texas Health Science Center, Houston |
2015-10 | |
| NCT02210325 | COMPLETED | Uncomplicated Urogenital Gonorrhea |
Melinta Therapeutics, Inc. |
2014-08 | PHASE3 |
| NCT03032042 | WITHDRAWN | Helminth Infection |
University of California, San Francisco |
2017-01 | PHASE4 |
| NCT02282176 | WITHDRAWN | Bronchopulmonary Dysplasia |
Institut National de la Santé Et de la Recherche Médicale, France |
2015-01 | PHASE3 |
| NCT02708992 | COMPLETED | Gonorrhoea |
National Institute of Allergy and Infectious Diseases (NIAID) |
2016-04-28 | PHASE1 |
| NCT02196493 | UNKNOWN | Chronic Cough |
University of Nottingham |
2013-12 | PHASE3 |
| NCT01778634 | COMPLETED | Ureaplasma Infections |
University of Maryland, Baltimore |
2013-07 | PHASE2 |
| NCT02344628 | COMPLETED | Yaws |
London School of Hygiene and Tropical Medicine |
2015-06 | PHASE3 |
| NCT02622802 | COMPLETED | Pregnancy |
University Hospital, Gasthuisberg |
2012-11 | |
| NCT02926326 | COMPLETED | Interaction |
Mereo BioPharma |
2016-09 | PHASE1 |
| NCT03629288 | COMPLETED | Periodontitis |
Universidad Nacional Andres Bello |
2016-03-01 | |
| NCT02527005 | COMPLETED | Malaria; Pregnant; HIV |
University of Ibadan |
2015-09 | PHASE1 |
| NCT02372383 | COMPLETED | Cystic Fibrosis |
University of Colorado, Denver |
2014-10 | |
| NCT03485703 | COMPLETED | Bronchopulmonary Dysplasia |
Hospital de Clinicas de Porto Alegre |
2012-08-28 | PHASE4 |
| NCT02600806 | UNKNOWN | Community-acquired Pneumonia |
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
2005-05 | PHASE4 |
| NCT01825031 | COMPLETED | Human Immunodeficiency Virus |
Anna Griffiths, MRC |
2013-06 | PHASE3 |
| NCT01618591 | TERMINATED | Acute Watery Diarrhea; Dysentery/Febrile Diarrhea |
Uniformed Services University of the Health Sciences |
2012-09 | |
| NCT02380625 | UNKNOWN | Ebola Virus Disease |
Clinical Research Management, Inc. |
2015-04 | PHASE1; PHASE2 |
| NCT02491723 | COMPLETED | Bronchiectasis |
Jin-Fu Xu |
2014-01 | |
| NCT00944515 | COMPLETED | Sinusitis |
Mahidol University |
2009-08 | |
| NCT01767506 | COMPLETED | Trachoma |
Johns Hopkins University |
2013-01 | |
| NCT01596894 | COMPLETED | Crohn's Disease |
Prof. Arie Levine |
2012-10 | PHASE4 |
| NCT01235546 | COMPLETED | Endometritis; Wound Infection; Abscess; Surgical Site Infection |
Alan Tita |
2011-05 | |
| NCT01919996 | TERMINATED | Pharyngitis; Tonsillitis |
Pfizer |
2013-12 | PHASE2 |
| NCT01661985 | UNKNOWN | Urethritis; Cervicitis; Genital Mycoplasma Infection; Chlamydia Trachomatis |
Ostergotland County Council, Sweden |
2010-02 | PHASE4 |
| NCT02362906 | UNKNOWN | Pneumonia |
Liaoning University of Traditional Chinese Medicine |
2014-04 | |
| NCT04870138 | COMPLETED | Gonococcal Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2013-03-10 | PHASE1 |
| NCT01272635 | COMPLETED | Asthma; Wheezing |
Milton S. Hershey Medical Center |
2011-03 | PHASE3 |
| NCT02224040 | UNKNOWN | Typhoid Fever |
Sheba Medical Center |
2013-08 | PHASE4 |
| NCT01617083 | COMPLETED | PANS; PANDAS; Obsessive Compulsive Disorder (OCD) |
University of South Florida |
2012-05 | PHASE2 |
| NCT01259141 | COMPLETED | Mycoplasma Pneumonia |
Capital Medical University |
2010-10 | |
| NCT01800942 | COMPLETED | Neonatal Infection |
London School of Hygiene and Tropical Medicine |
2013-02 | PHASE3 |
| NCT01721616 | WITHDRAWN | Endometritis |
University of Missouri, Kansas City |
2012-11 | PHASE4 |
| NCT01307462 | COMPLETED | Bronchiolitis Obliterans |
Stephanie Lee |
2011-06 | PHASE2 |
| NCT02176057 | WITHDRAWN | Trachoma |
University of California, San Francisco |
2014-08 | PHASE2; PHASE3 |
| NCT02023554 | COMPLETED | Chronic Obstructive Pulmonary Disease; Asthma |
Zhujiang Hospital |
2013-12 | |
| NCT01444469 | COMPLETED | Asthma |
Imperial College London |
2011-09 | PHASE4 |
| NCT01825408 | COMPLETED | Sinusitis |
University of North Carolina, Chapel Hill |
2013-02 | PHASE4 |
| NCT00980148 | COMPLETED | Chlamydial Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2009-12-02 | PHASE3 |
| NCT01486758 | COMPLETED | RSV Bronchiolitis |
Washington University School of Medicine |
2011-12 | PHASE2 |
| NCT02215460 | COMPLETED | Periodontitis |
University of Taubate |
2012-04 | PHASE4 |
| NCT01903057 | WITHDRAWN | Trachoma; Lymphatic Filariasis |
Emory University |
2014-02 | PHASE4 |
| NCT02126267 | COMPLETED | Periodontal Disease; Chronic Periodontitis |
Centro Universitario de Lavras |
2013-01 | |
| NCT01769027 | WITHDRAWN | Pandas |
CNS Onlus |
2013-06 | PHASE2 |
| NCT02107274 | COMPLETED | Bronchiectasis |
Penang Hospital, Malaysia |
2011-11 | PHASE4 |
| NCT01783340 | WITHDRAWN | Malaria, Falciparum |
Radboud University Medical Center |
2013-04 | PHASE1; PHASE2 |
| NCT01531218 | COMPLETED | Diarrhea; Fever; Vomiting; Abdominal Pain |
University of Aarhus |
2012-03 | PHASE3 |
| NCT00411736 | COMPLETED | Cystic Fibrosis |
Rigshospitalet, Denmark |
2008-05 | PHASE4 |
| NCT01202331 | COMPLETED | Trachoma; Chlamydia |
University of California, San Francisco |
2010-11 | PHASE4 |
| NCT00708799 | TERMINATED | Systemic Inflammatory Response Syndrome |
VA Office of Research and Development |
2007-11 | PHASE2 |
| NCT01103063 | TERMINATED | Intermittent Preventive Treatment In Pregnancy (IPTp) |
Pfizer |
2010-10 | PHASE3 |
| NCT01783860 | COMPLETED | Posterior Blepharitis |
Tehran University of Medical Sciences |
2013-01 | PHASE2 |
| NCT01876108 | COMPLETED | Fatty Liver; Liver Dysfunction; Insulin Resistance |
Tehran University of Medical Sciences |
2012-07 | PHASE2 |
| NCT01103713 | TERMINATED | Asymptomatic Parasitemia In Pregnancy |
Pfizer |
2011-03 | PHASE3 |
| NCT00792922 | COMPLETED | Trachoma |
Johns Hopkins University |
2008-05 | PHASE4 |
| NCT01327625 | TERMINATED | Graft vs Host Disease; Bronchiolitis Obliterans |
Asan Medical Center |
2011-03 | |
| NCT01921738 | COMPLETED | Chronic Periodontitis |
Isfahan University of Medical Sciences |
2012-05 | PHASE2 |
| NCT01721694 | WITHDRAWN | Ocular Inflammation; Infection Associated Blepharitis; Keratitis; Conjunctivitis, Bacterial |
Adapt Produtos Oftalmológicos Ltda. |
2012-12 | PHASE3 |
| NCT01398072 | UNKNOWN | Chronic Obstructive Pulmonary Disease (COPD). |
University College, London |
2011-12 | PHASE3 |
| NCT01560962 | TERMINATED | Blepharitis |
Southern California Institute for Research and Education |
2012-01 | |
| NCT01008761 | UNKNOWN | Asthma |
Janielee Williamson |
2010-01 | |
| NCT01432080 | TERMINATED | Respiratory Tract Infections; Bronchiolitis Obliterans; Cryptogenic Organizing Pneumonia; Lung Diseases, Interstitial |
Maisonneuve-Rosemont Hospital |
2011-09 | PHASE2 |
| NCT00926796 | COMPLETED | Gonorrhoea |
National Institute of Allergy and Infectious Diseases (NIAID) |
2010-06 | PHASE4 |
| NCT01323582 | TERMINATED | Gastroparesis |
University of Florida |
2009-02 | PHASE2 |
| NCT01374126 | COMPLETED | Falciparum Malaria |
Medical University of Vienna |
2011-07 | PHASE2 |
| NCT01109160 | COMPLETED | Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation |
KU Leuven |
2010-04 | PHASE4 |
| NCT01556334 | WITHDRAWN | Preterm Premature Ruptured Membranes |
Indiana University |
2010-04 | PHASE3 |
| NCT01469702 | UNKNOWN | Cat-scratch Disease; Bartonella Infections |
Tel-Aviv Sourasky Medical Center |
2011-12 | PHASE4 |
| NCT00319956 | COMPLETED | Bronchopulmonary Dysplasia |
Hubert Ballard |
2004-09 | PHASE2 |
| NCT01089608 | COMPLETED | Blepharitis |
Laboratoires Thea |
2010-03 | PHASE2 |
| NCT01071161 | COMPLETED | Cough; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis |
Isala |
2009-09 | PHASE3 |
| NCT00682656 | TERMINATED | Cutaneous Leishmaniasis |
Ana Rabello |
2008-06 | PHASE2; PHASE3 |
| NCT00358462 | COMPLETED | Urethritis |
University of Washington |
2007-01 | PHASE3 |
| NCT01667692 | COMPLETED | Peptic Ulcer; Dyspepsia; H-pylori |
Shahid Sadoughi University of Medical Sciences and Health Services |
2011-03 | PHASE4 |
| NCT01072136 | TERMINATED | Vaginitis Bacterial; Cervicitis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2010-03 | PHASE3 |
| NCT01382004 | COMPLETED | Yaws; Treponema Infection; Neglected Tropical Disease |
Lihir Medical Centre |
2010-09 | PHASE3 |
| NCT01220258 | TERMINATED | Posterior Blepharoconjunctivitis |
Merck Sharp & Dohme LLC |
2010-11 | PHASE2 |
| NCT00852579 | COMPLETED | Asthma |
Euan J Cameron |
2009-03 | PHASE3 |
| NCT05299567 | COMPLETED | Bronchiolitis Obliterans |
Claudio Castanos |
2010-08-24 | PHASE4 |
| NCT01154569 | COMPLETED | Bariatric Surgery |
University of Alberta |
2010-06 | |
| NCT01269658 | TERMINATED | Blepharitis |
Merck Sharp & Dohme LLC |
2010-12 | PHASE2 |
| NCT01416350 | COMPLETED | Autoimmune Diseases |
GlaxoSmithKline |
2011-03-30 | PHASE1 |
| NCT00760838 | COMPLETED | Asthma |
University Hospital, Ghent |
2009-03 | PHASE4 |
| NCT01105624 | COMPLETED | Contact Lens Dry Eye |
Merck Sharp & Dohme LLC |
2010-03 | PHASE4 |
| NCT01243008 | COMPLETED | Lyme Disease |
University of Zurich |
2010-04 | PHASE1; PHASE2 |
| NCT01169038 | COMPLETED | Pulmonary Sarcoidosis; Lung Function |
Vanderbilt University |
2010-07 | PHASE1 |
| NCT00871494 | COMPLETED | Pelvic Inflammatory Disease |
Pfizer |
2009-05 | PHASE3 |
| NCT00677833 | COMPLETED | Malaria, Falciparum |
Pfizer |
2008-06 | PHASE2; PHASE3 |
| NCT01100060 | COMPLETED | Malaria Prophylaxis |
Pfizer |
2010-04 | PHASE1 |
| NCT00325897 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
University of Minnesota |
2006-03 | |
| NCT01217099 | TERMINATED | Refractory Mycoplasma Pneumoniae Pneumonia |
Chongqing Medical University |
2007-05 | |
| NCT01014078 | COMPLETED | Dry Eye Disease |
Merck Sharp & Dohme LLC |
2009-10 | PHASE4 |
| NCT00809328 | COMPLETED | Community Acquired Pneumonia (CAP) |
Pfizer |
2009-02 | PHASE3 |
| NCT01586169 | COMPLETED | Parasitic Diseases; Bacterial Diseases |
Centre d'Appui à la lutte contre la Maladie |
2010-02 | |
| NCT00892970 | COMPLETED | Blepharitis |
Merck Sharp & Dohme LLC |
2009-04 | PHASE2 |
| NCT00415350 | COMPLETED | Bronchiectasis; Inflammation |
W.G.Boersma |
2008-04 | PHASE3 |
| NCT00894530 | COMPLETED | Blepharitis |
Merck Sharp & Dohme LLC |
2009-05 | PHASE2 |
| NCT01009619 | COMPLETED | Bronchiolitis Obliterans Syndrome; Graft Rejection; Lymphocytic Bronchiolitis; Respiratory Infection |
KU Leuven |
2005-09 | PHASE4 |
| NCT01026064 | COMPLETED | Inflammation |
GlaxoSmithKline |
2009-06-04 | PHASE1 |
| NCT00322972 | COMPLETED | Trachoma; Chlamydia |
University of California, San Francisco |
2006-06 | PHASE4 |
| NCT01348321 | COMPLETED | Acne |
Ahvaz Jundishapur University of Medical Sciences |
2008-11 | PHASE2; PHASE3 |
| NCT00379821 | COMPLETED | Plasmodium Falciparum Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2007-02 | PHASE3 |
| NCT00879983 | COMPLETED | Healthy Volunteers |
Pfizer |
2009-05 | PHASE1 |
| NCT00599053 | TERMINATED | Bacteria Infection; Respiratory Tract Infections |
University of Alabama at Birmingham |
2007-05 | PHASE1; PHASE2 |
| NCT00618449 | COMPLETED | Trachoma; Chlamydia Trachomatis |
University of California, San Francisco |
2008-01 | PHASE4 |
| NCT00717561 | COMPLETED | Pneumonia |
Bayer |
2008-02 | PHASE3 |
| NCT00322465 | COMPLETED | Urethritis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-11-17 | PHASE2 |
| NCT00844207 | COMPLETED | Malaria |
Pfizer |
2009-02 | PHASE1 |
| NCT00298922 | UNKNOWN | Cystic Fibrosis |
Unity Health Toronto |
2006-02 | PHASE2 |
| NCT00796224 | COMPLETED | Acute Otitis Media |
Pfizer |
2008-12 | PHASE2 |
| NCT00694694 | COMPLETED | Malaria |
London School of Hygiene and Tropical Medicine |
2008-06 | PHASE3 |
| NCT00575367 | COMPLETED | Bacterial Infections; Eye Infections |
Merck Sharp & Dohme LLC |
2008-03 | PHASE4 |
| NCT00741052 | COMPLETED | Cholera |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2007-07 | PHASE3 |
| NCT00578955 | COMPLETED | Blepharoconjunctivitis |
Sun Pharmaceutical Industries Limited |
2007-12 | PHASE3 |
| NCT00351273 | COMPLETED | Arthritis, Reactive; Reiter Disease |
University of South Florida |
2006-05 | PHASE3 |
| NCT00983294 | COMPLETED | Pharmacokinetics |
Mutual Pharmaceutical Company, Inc. |
2008-07 | PHASE1 |
| NCT00629941 | COMPLETED | Blepharitis |
Merck Sharp & Dohme LLC |
2008-03 | PHASE4 |
| NCT00254566 | COMPLETED | Chronic Bronchitis |
Pfizer |
2006-02 | PHASE3 |
| NCT00524095 | TERMINATED | Bronchiectasis; Pulmonary Disease; Chronic Bronchitis |
University of Milan |
2006-09 | PHASE2 |
| NCT00392223 | TERMINATED | Acne Vulgaris |
Pfizer |
2007-10 | PHASE3 |
| NCT00575380 | COMPLETED | Bacterial Infections; Eye Infections; Cataract Extraction |
Merck Sharp & Dohme LLC |
2007-12 | PHASE4 |
| NCT00599079 | COMPLETED | Mycobacterium Avium Complex Lung Disease |
The University of Texas Health Science Center at Tyler |
1993-02 | PHASE4 |
| NCT00282919 | COMPLETED | Falciparum Malaria |
Pfizer |
2006-03 | PHASE2 |
| NCT00419848 | UNKNOWN | Acne |
Shahid Beheshti University of Medical Sciences |
2006-08 | PHASE2 |
| NCT00883818 | COMPLETED | Overactive Bladder |
Samsung Medical Center |
2007-01 | PHASE4 |
| NCT01178762 | COMPLETED | Chlamydial Conjunctivitis |
National Taiwan University Hospital |
2007-09 | |
| NCT00367653 | COMPLETED | Malaria |
Pfizer |
2006-11 | PHASE3 |
| NCT00031499 | COMPLETED | Syphilis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2000-06 | PHASE3 |
| NCT00286026 | WITHDRAWN | Trachoma |
University of California, San Francisco |
2005-06 | PHASE4 |
| NCT00356005 | COMPLETED | Uncomplicated Falciparum Malaria |
Medical University of Vienna |
2006-08 | PHASE2 |
| NCT00131235 | ACTIVE_NOT_RECRUITING | Malaria; Sexually Transmitted Diseases; Preterm Birth; Pregnancy |
Tampere University |
2003-12 | PHASE3 |
| NCT00360464 | COMPLETED | Acute Bronchitis |
Pfizer |
2006-10 | PHASE3 |
| NCT00393835 | COMPLETED | Upper Respiratory Tract Infection |
Pfizer |
2006-11 | PHASE3 |
| NCT00360295 | COMPLETED | Pneumonia, Community-Acquired |
Pfizer |
2006-09 | PHASE3 |
| NCT01463371 | COMPLETED | Bronchiectasis |
Instituto de Investigacion Sanitaria La Fe |
2006-10 | |
| NCT00315601 | TERMINATED | Healthy |
University of Illinois at Chicago |
2006-01 | PHASE4 |
| NCT00598962 | COMPLETED | Mycobacterium Avium Complex |
The University of Texas Health Science Center at Tyler |
1994-12 | PHASE4 |
| NCT00132951 | TERMINATED | Respiratory Tract Infections; Chronic Bronchitis; Pneumonia |
Sanofi |
2004-10 | PHASE4 |
| NCT00237445 | TERMINATED | Pneumonia |
Sanofi |
2005-11 | PHASE4 |
| NCT00315003 | TERMINATED | Otitis Media, Suppurative; Otitis Media, Purulent |
Sanofi |
2006-01 | PHASE3 |
| NCT00181272 | TERMINATED | Asthma; Chronic Obstructive Pulmonary Disease |
Johns Hopkins University |
2005-09 | PHASE2 |
| NCT00232154 | COMPLETED | Sinusitis |
Pfizer |
2005-11 | PHASE2 |
| NCT00324818 | COMPLETED | Bacterial Vaginosis |
University of Alabama at Birmingham |
2002-07 | PHASE4 |
| NCT00830336 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2005-10 | PHASE1 |
| NCT00610623 | TERMINATED | Pneumonia, Ventilator-Associated; Pseudomonas Infections |
Anbics Management-Services Ag |
2003-04 | PHASE2 |
| NCT00299208 | COMPLETED | Plasmodium Falciparum Malaria |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00057486 | TERMINATED | HIV Infections; Cryptosporidiosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
1997-09 | PHASE1; PHASE2 |
| NCT00001128 | TERMINATED | Cryptosporidiosis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00649935 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2005-05 | PHASE1 |
| NCT00650273 | COMPLETED | Healthy |
Mylan Pharmaceuticals Inc |
2005-04 | PHASE1 |
| NCT00875966 | COMPLETED | Infections |
Sandoz |
2004-08 | PHASE1 |
| NCT00538148 | COMPLETED | Bronchitis, Chronic |
Sanofi |
2002-11 | PHASE4 |
| NCT00645112 | COMPLETED | Acute Otitis Media |
Abbott |
2003-11 | PHASE4 |
| NCT00347776 | COMPLETED | Trichiasis |
Johns Hopkins University |
2001-08 | PHASE4 |
| NCT00865670 | COMPLETED | Infection |
Sandoz |
2003-08 | PHASE1 |
| NCT00866216 | COMPLETED | Infection |
Sandoz |
2003-08 | PHASE1 |
| NCT00359970 | COMPLETED | Diarrhea |
The University of Texas Health Science Center, Houston |
2002-06 | PHASE4 |
| NCT00644774 | COMPLETED | Healthy |
Abbott |
2003-01 | PHASE4 |
| NCT00834756 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2002-09 | PHASE1 |
| NCT00834132 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2002-07 | PHASE1 |
| NCT00357383 | COMPLETED | Eye Infections, Bacterial |
Laboratoires Thea |
2002-10 | PHASE1 |
| NCT00042718 | COMPLETED | Bronchitis; Chronic Bronchitis |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2001-11 | PHASE3 |
| NCT00229944 | COMPLETED | Cholera |
International Centre for Diarrhoeal Disease Research, Bangladesh |
2002-12 | PHASE3 |
| NCT00643227 | COMPLETED | Pneumonia |
Pfizer |
2003-01 | PHASE3 |
| NCT00245453 | WITHDRAWN | Pneumonia, Bacterial; Bronchitis, Chronic |
CPL Associates |
2005-10 | PHASE4 |
| NCT00356850 | COMPLETED | Eye Infections, Bacterial |
Laboratoires Thea |
2002-05 | PHASE1 |
| NCT00002328 | COMPLETED | Cryptosporidiosis; HIV Infections |
Pfizer |
||
| NCT00000617 | COMPLETED | Coronary Disease; Heart Diseases; Myocardial Infarction; Cardiovascular Diseases |
National Heart, Lung, and Blood Institute (NHLBI) |
1998-09 | PHASE3 |
| NCT00132860 | UNKNOWN | Pulmonary Disease, Chronic Obstructive |
Odense University Hospital |
2001-05 | PHASE4 |
| NCT00140023 | COMPLETED | Community-Acquired Pneumonia |
Pfizer |
2005-09 | PHASE3 |
| NCT00643539 | COMPLETED | Tonsillitis |
Pfizer |
2002-12 | PHASE4 |
| NCT00043264 | COMPLETED | Multiple Sclerosis |
National Center for Research Resources (NCRR) |
PHASE2 | |
| NCT00644176 | COMPLETED | Pharmacokinetics |
Pfizer |
2004-11 | PHASE2 |
| NCT00471809 | TERMINATED | Asthma |
National Heart, Lung, and Blood Institute (NHLBI) |
2006-03 | PHASE4 |
| NCT00323986 | TERMINATED | COPD; Tracheostomy |
University of Milan |
2004-10 | PHASE2 |
| NCT00648726 | COMPLETED | Pneumonia |
Pfizer |
2003-01 | PHASE3 |
| NCT00821782 | COMPLETED | Healthy Volunteer |
Ortho-McNeil Janssen Scientific Affairs, LLC |
2006-06 | PHASE1 |
| NCT00245440 | TERMINATED | Maxillary Sinusitis |
CPL Associates |
2005-12 | PHASE4 |
| NCT00001023 | COMPLETED | Mycobacterium Avium-intracellulare Infection; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00082563 | TERMINATED | Malaria, Falciparum |
Pfizer |
2004-08 | PHASE2 |
| NCT00357773 | COMPLETED | Conjunctivitis, Bacterial |
Laboratoires Thea |
2004-05 | PHASE3 |
| NCT00357539 | COMPLETED | Eye Infections, Bacterial |
Laboratoires Thea |
2002-02 | PHASE1 |
| NCT00000895 | COMPLETED | Mycobacterium Avium-intracellulare Infection; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00035347 | COMPLETED | Community-Acquired Pneumonia (CAP) |
Pfizer |
2001-01 | PHASE4 |
| NCT00000641 | COMPLETED | Mycobacterium Avium-intracellulare Infection; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00084240 | TERMINATED | Malaria, Falciparum |
Pfizer |
2004-03 | PHASE2; PHASE3 |
| NCT00643149 | COMPLETED | Tonsillitis |
Pfizer |
2003-05 | PHASE3 |
| NCT00357292 | COMPLETED | Eye Infections, Bacterial |
Laboratoires Thea |
2002-03 | PHASE1 |
| NCT00164112 | COMPLETED | Healthy |
Bassett Healthcare |
2004-11 | PHASE4 |
| NCT00002192 | COMPLETED | Mycobacterium Avium-Intracellulare Infection; HIV Infections |
Anderson Clinical Research |
PHASE2 | |
| NCT00644449 | COMPLETED | Bronchitis, Chronic |
Pfizer |
2003-01 | PHASE3 |
| NCT00153634 | COMPLETED | Cystic Fibrosis; Chronic Bronchitis |
Seattle Children's Hospital |
2004-03 | |
| NCT00002122 | COMPLETED | Mycoses; Mycobacterium Avium-Intracellulare Infection; HIV Infections |
Pfizer |
PHASE3 | |
| NCT00649831 | COMPLETED | Bronchitis, Chronic |
Pfizer |
2002-10 | PHASE3 |
| NCT00367120 | COMPLETED | Sinusitis |
Pfizer |
2006-06 | PHASE4 |
| NCT00074841 | COMPLETED | PLASMODIUM FALCIPARUM MALARIA |
Pfizer |
2003-09 | PHASE2; PHASE3 |
| NCT00644293 | COMPLETED | Pharyngitis; Tonsillitis |
Pfizer |
2003-01 | PHASE3 |
| NCT00000811 | COMPLETED | Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002082 | COMPLETED | Cryptosporidiosis; HIV Infections |
Pfizer |
||
| NCT00002085 | COMPLETED | Mycobacterium Avium-Intracellulare Infection; HIV Infections; Tuberculosis, Mycobacterium Infection |
Pfizer |
||
| NCT00084227 | COMPLETED | Malaria, Falciparum |
Pfizer |
2004-07 | PHASE2; PHASE3 |
| NCT00643734 | COMPLETED | Pneumonia |
Pfizer |
2003-04 | PHASE3 |
| NCT00002309 | COMPLETED | Mycobacterium Avium-Intracellulare Infection; HIV Infections |
Pfizer |
||
| NCT00643409 | COMPLETED | Maxillary Sinusitis |
Pfizer |
2003-01 | PHASE3 |
| NCT00000947 | COMPLETED | Mycobacterium Avium-intracellulare Infection; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00002090 | COMPLETED | Mycobacterium Avium-Intracellulare Infection; HIV Infections |
Pfizer |
||
| NCT00356772 | COMPLETED | Eye Infections, Bacterial |
Laboratoires Thea |
2003-02 | PHASE1 |
| NCT00643292 | COMPLETED | Acute Otitis Media |
Pfizer |
2003-01 | PHASE3 |
| NCT00127504 | COMPLETED | Onchocerciasis |
Centers for Disease Control and Prevention |
2003-07 | PHASE2 |
| NCT00245908 | COMPLETED | Asthma |
Wisconsin Research Network |
1999-09 | PHASE3 |
| NCT00000883 | COMPLETED | Mycobacterium Avium-intracellulare Infection; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
1997-10 | |
| NCT00563251 | COMPLETED | Bronchiolitis Obliterans; Bone Marrow Transplantation |
Hospital Authority, Hong Kong |
2005-04 | |
| NCT00137007 | COMPLETED | Pneumonia |
Pfizer |
2003-11 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-06-13)
Check the
Azithromycin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.