Clinical Trials
Numerous clinical trials evaluate sulfamethoxazole for bacterial infections, urinary tract infections, Pneumocystis jirovecii pneumonia, skin diseases, and pediatric and adult pharmacokinetic profiling to optimize dosing regimens. Spanning Phase 1 through Phase 4 alongside non-interventional protocols, these studies encompass completed, recruiting, and terminated recruitment statuses. The evaluations are sponsored by academic and governmental institutions, including Duke University, Baylor College of Medicine, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| 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 |
| NCT04851015 | RECRUITING | Pneumocystis; Pneumocystis Pneumonia; Pneumocystis Jirovecii Infection; Pneumocystis Infections; Pneumocystis Carinii Infection; Pneumocystosis; Pneumonia (Etiology); Pneumocystis Carinii; Infection, Resulting From HIV Disease; Pneumocystosis Associated With AIDS |
Todd C. Lee MD MPH FIDSA |
2025-11-28 | PHASE3 |
| NCT07665359 | NOT_YET_RECRUITING | Chronic Obstructive Pulmonary Disease (COPD) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-07-01 | |
| NCT07106125 | NOT_YET_RECRUITING | Kidney Transplant; Urinary Tract Infection(UTI); Antibiotic Prophylaxis; Remote Patient Monitoring; Feasibility Pilot Study |
University of California, San Francisco |
2026-11 | PHASE4 |
| NCT07619027 | NOT_YET_RECRUITING | Pneumocystis Jirovecii Pneumonia; Kidney Transplantation |
Anhui Provincial Hospital |
2026-06 | PHASE4 |
| NCT05925309 | RECRUITING | Biliary Atresia; Cholangitis; Anti-Bacterial Agents |
Children's Hospital of Fudan University |
2023-07-01 | |
| NCT03178149 | RECRUITING | Age-Related Macular Degeneration |
Astellas Institute for Regenerative Medicine |
2018-07-13 | PHASE1 |
| NCT03919435 | ACTIVE_NOT_RECRUITING | Granulomatosis With Polyangiitis; Wegener Granulomatosis |
University of Pennsylvania |
2019-03-27 | PHASE1; PHASE2 |
| NCT07228702 | ENROLLING_BY_INVITATION | Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection |
Vancouver Coastal Health |
2026-01-11 | PHASE1 |
| NCT05224401 | RECRUITING | Urinary Tract Infections; Bacteremia; Antibiotic Resistant Infection |
Lund University |
2023-05-29 | PHASE3 |
| NCT07224997 | NOT_YET_RECRUITING | Acute Kidney Injuries; Acute Kidney Disease; Acute Kidney Injury (AKI) |
Hospital Civil de Guadalajara |
2025-12-01 | PHASE2 |
| NCT06982105 | RECRUITING | Methicillin Resistant Staphylococcus Aureus; Osteomyelitis Acute; Septic Arthritis; Orbital Cellulitis; Facial Cellulitis; Mastoiditis; Cervical Adenitis; Retropharyngeal Abscess; Peritonsillar Abscess |
Indiana University |
2025-05-20 | PHASE4 |
| NCT05678621 | RECRUITING | Haematological Malignancy; Hypogammaglobulinemia |
Monash University |
2022-11-30 | PHASE2; PHASE3 |
| NCT07202052 | RECRUITING | Myeloma; Non-Hodgkin's Lymphoma; Leukemia |
Monash University |
2025-05-06 | PHASE2; PHASE3 |
| NCT07202078 | RECRUITING | Myeloma; Non Hodgkin's Lymphoma; Leukemia |
Monash University |
2025-05-07 | PHASE2; PHASE3 |
| NCT07202091 | RECRUITING | Myeloma; Leukemia; Non Hodgkin's Lymphoma |
Monash University |
2025-05-06 | PHASE2; PHASE3 |
| NCT01631617 | RECRUITING | Eczema; Dermatitis; Skin Diseases, Genetic; Dermatitis, Atopic; Skin Diseases |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
2012-09-18 | PHASE2 |
| NCT06709196 | RECRUITING | Cystectomy; Bladder Cancer Requiring Cystectomy; Postoperative Infections; Antibiotic Prophylaxis; Ileal Conduit |
Rigshospitalet, Denmark |
2025-01-07 | PHASE4 |
| NCT07772752 | RECRUITING | Drug-induced Crystalline Nephropathy; Drug-induced Crystalluria; Infections Treated With Sulfamethoxazole, High Dose Ciprofloxacin or High Dose iv Amoxicillin |
Universitair Ziekenhuis Brussel |
2025-12-08 | |
| NCT05398679 | RECRUITING | Endocarditis Infective |
Fundacion Clinic per a la Recerca Biomédica |
2022-08-17 | PHASE4 |
| NCT07451171 | RECRUITING | Small Intestine Bacterial Overgrowth |
University of Virginia |
2026-04-18 | PHASE2 |
| NCT06841705 | RECRUITING | Immune Checkpoint Inhibitor-Related Colitis |
Shilpa Grover, MD, MPH |
2025-07-15 | PHASE2 |
| NCT06499233 | RECRUITING | Pneumonia, Pneumocystis; Autoimmune Inflammatory Rheumatic Disease; Autoimmune Diseases; Connective Tissue Disease; Prevention |
Tongji Hospital |
2024-07-20 | PHASE4 |
| NCT05199324 | COMPLETED | Gram-negative Bacteraemia |
Tan Tock Seng Hospital |
2022-06-03 | PHASE4 |
| NCT06737016 | RECRUITING | Posterior Urethral Valve |
Mansoura University |
2024-11-01 | PHASE3 |
| NCT07231770 | RECRUITING | Fever; Chest Tightness |
Anhui Provincial Hospital |
2024-05-28 | |
| NCT04368559 | COMPLETED | Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis; Pneumocystis; Mold Infection; Invasive Fungal Disease; Prophylaxis of Invasive Fungal Infections; Aspergillus |
Mundipharma Research Limited |
2020-05-11 | PHASE3 |
| NCT03489629 | COMPLETED | Cystic Fibrosis |
University of North Carolina, Chapel Hill |
2018-04-03 | PHASE2 |
| NCT06394674 | RECRUITING | Non-Small Cell Lung Cancer |
Changhai Hospital |
2024-05-01 | PHASE2 |
| NCT06336824 | UNKNOWN | Staphylococcus Aureus Bacteremia |
Clinical Research Centre, Malaysia |
2024-06-28 | PHASE3 |
| NCT04502095 | COMPLETED | Bladder Carcinoma; Refractory Bladder Carcinoma; Urinary Tract Infection |
Roswell Park Cancer Institute |
2020-09-02 | PHASE4 |
| NCT05274672 | WITHDRAWN | Benign Prostatic Hyperplasia; Urinary Tract Infections |
Baylor Research Institute |
2023-03-01 | PHASE4 |
| NCT02944825 | COMPLETED | Urolithiasis; UTI |
University of California, San Diego |
2016-01 | |
| NCT05302531 | UNKNOWN | Short Bowel Syndrome; Infection, Bacterial |
Central Hospital, Nancy, France |
2022-12-09 | PHASE1 |
| NCT03637400 | COMPLETED | Methicillin-resistant Staphylococcus Aureus; Skin Infection |
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
2018-11-26 | PHASE2 |
| NCT05577273 | UNKNOWN | Urologic Diseases; Urinary Tract Disease |
Omri Schwarztuch Gildor |
2018-08-14 | |
| NCT05418777 | TERMINATED | COPD Exacerbation Acute |
Corewell Health East |
2022-09-28 | PHASE1; PHASE2 |
| NCT03978559 | UNKNOWN | Pneumocystis Pneumonia |
Bin Du |
2019-08-14 | PHASE4 |
| NCT03173053 | TERMINATED | Staphylococcus Aureus; Motility Disorder |
Radboud University Medical Center |
2018-02-08 | |
| NCT03228108 | COMPLETED | Complication; Infection; Prostate Cancer |
Radboud University Medical Center |
2018-04-03 | PHASE4 |
| NCT05817253 | Completed | Clinical Audit|Quality Improvement |
University of British Columbia|Ministry of Health British Columbia |
2021-09-23 | Not Applicable |
| NCT03042260 | UNKNOWN | Lupus Erythematosus, Systemic |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2017-03-01 | PHASE4 |
| NCT02734732 | UNKNOWN | Prostate Infection |
Umeå University |
2015-04 | PHASE2 |
| NCT01792804 | COMPLETED | Staphylococcus Aureus Infection |
Heinrich-Heine University, Duesseldorf |
2013-12 | PHASE3 |
| NCT02021006 | UNKNOWN | Vesicoureteral Reflux; Renal Hypodysplasia, Nonsyndromic, 1; Chronic Kidney Disease |
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
2013-12 | PHASE3 |
| NCT01595529 | COMPLETED | Urinary Tract Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2012-05-18 | PHASE2 |
| NCT03014687 | RECRUITING | Antibiotics; Pituitary Adenoma |
St. Joseph's Hospital and Medical Center, Phoenix |
2017-07-01 | PHASE4 |
| NCT02096159 | ACTIVE_NOT_RECRUITING | Hypospadias |
Ann & Robert H Lurie Children's Hospital of Chicago |
2014-03 | |
| NCT02475876 | COMPLETED | Bacterial Infections |
Michael Cohen-Wolkowiez |
2015-11 | PHASE1 |
| NCT01650558 | COMPLETED | HIV |
University of Maryland, Baltimore |
2012-11 | |
| NCT01723150 | COMPLETED | Liver Abscess, Pyogenic |
National University Hospital, Singapore |
2013-11-05 | PHASE4 |
| NCT01594827 | COMPLETED | Cystic Fibrosis |
Johns Hopkins University |
2012-10 | PHASE2 |
| NCT03235947 | COMPLETED | Urinary Tract Infection; Asymptomatic Bacteriuria |
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
2016-09-07 | PHASE4 |
| NCT02640443 | UNKNOWN | Hypotonia Cystinuria Syndrome; Isolated PREPL Deficiency |
Universitair Ziekenhuis Brussel |
2015-10 | PHASE2 |
| NCT02624440 | UNKNOWN | Multiple Myeloma; Infection |
Henrik Gregersen |
2013-01 | PHASE2 |
| NCT01632891 | COMPLETED | HIV-1 Infection; Pf Subclinical Parasitemia |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2014-01-10 | PHASE1; PHASE2 |
| NCT02282293 | COMPLETED | Malaria; Human Immunodeficiency Virus |
University of California, San Francisco |
2014-12-09 | PHASE3 |
| NCT01757236 | UNKNOWN | Hip Prosthetic Joint Infection |
University Hospital, Tours |
2012-10 | PHASE2 |
| NCT01777737 | TERMINATED | Idiopathic Pulmonary Fibrosis |
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
2013-11-25 | PHASE3 |
| NCT02475876 | Completed | Bacterial Infections |
Michael Cohen-Wolkowiez|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Duke University |
2015-11 | Phase 1 |
| NCT01659866 | COMPLETED | Infection |
Northwestern University |
2012-08 | PHASE4 |
| NCT01820897 | COMPLETED | Urinary Tract Infection; Asymptomatic Bacteriuria; Allograft Rejection; Microbiologic Resistance; Hospitalization |
JOSE MANUEL ARREOLA GUERRA |
2013-04 | PHASE4 |
| NCT00730028 | COMPLETED | Staphylococcal Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2009-04 | PHASE2 |
| NCT01349192 | TERMINATED | Cystic Fibrosis; Methicillin-resistant Staphylococcus Aureus |
University of North Carolina, Chapel Hill |
2011-04 | PHASE2 |
| NCT00752375 | WITHDRAWN | Pyelonephritis |
University of Alberta |
2009-02 | PHASE3 |
| NCT01595438 | COMPLETED | Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis |
Pfizer |
2012-10 | PHASE3 |
| NCT01599806 | COMPLETED | Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis |
Pfizer |
2012-10 | PHASE3 |
| NCT01507974 | COMPLETED | Pregnancy Complications |
HaEmek Medical Center, Israel |
2012-01-16 | |
| NCT00948896 | COMPLETED | Malaria |
University of California, San Francisco |
2010-06 | PHASE3 |
| NCT00711854 | COMPLETED | MRSA Infection |
University Hospital, Geneva |
2009-01 | PHASE4 |
| NCT01449877 | COMPLETED | Ocular Toxoplasmosis |
University of Campinas, Brazil |
2011-10 | PHASE3 |
| NCT01425073 | COMPLETED | HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression; Immune System Diseases; Malaria; Parasitic Diseases; Pneumonia; Diarrhea; Infectious Disorder of Immune System |
University of Washington |
2012-02 | |
| NCT01747278 | UNKNOWN | Pneumonia, Pneumocystis; Prevention & Control |
Peking Union Medical College Hospital |
2012-08 | PHASE2; PHASE3 |
| NCT00405704 | COMPLETED | Vesicoureteral Reflux; Urinary Tract Infections |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2007-05 | PHASE3 |
| NCT00729937 | COMPLETED | Staphylococcal Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2009-04 | PHASE2; PHASE3 |
| NCT00527800 | COMPLETED | Malaria; HIV Infections |
University of California, San Francisco |
2007-08 | PHASE3 |
| NCT00867789 | TERMINATED | Abscess |
Children's Mercy Hospital Kansas City |
2009-03 | |
| NCT01808755 | COMPLETED | Recurrent Urinary Tract Infection |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2012-01 | PHASE3 |
| NCT00676130 | COMPLETED | Cellulitis |
Brigham and Women's Hospital |
2007-05 | |
| NCT01167452 | COMPLETED | Obesity; Pharmacokinetics; MRSA; Tuberculosis; PCP |
Texas Tech University Health Sciences Center |
2010-07 | PHASE4 |
| NCT02024867 | COMPLETED | Skin Disease, Bacterial; Abscess |
Lucy Holmes, MD |
2010-02 | |
| NCT01469637 | COMPLETED | Healthy |
Shire |
2011-11-07 | PHASE1 |
| NCT00613769 | COMPLETED | Infection Prophylaxis in Colo Rectal Surgery |
Halmstad County Hospital |
2007-09 | PHASE4 |
| NCT00900510 | WITHDRAWN | Abscess |
Wake Forest University |
2009-05 | |
| NCT00002850 | COMPLETED | Infection; Multiple Myeloma |
Gary Morrow |
1997-03 | PHASE3 |
| NCT01137903 | UNKNOWN | Osteomyelitis; Diabetic Foot; Diabetic Foot Ulcers |
Universidad Complutense de Madrid |
2010-04 | |
| NCT00869518 | TERMINATED | Staphylococcus Aureus; HIV Infections |
University of California, San Francisco |
2009-07 | PHASE2 |
| NCT01167452 | Completed | Obesity|Pharmacokinetics|MRSA|Tuberculosis|PCP |
Texas Tech University Health Sciences Center|National Center for Research Resources (NCRR)|University of Texas Southwestern Medical Center |
2010-07 | Phase 4 |
| NCT00691600 | COMPLETED | Abscess |
Baylor College of Medicine |
2007-12 | PHASE3 |
| NCT00080119 | TERMINATED | HIV Infection; Tuberculosis; Pneumocystis Jiroveci Pneumonia |
International Maternal Pediatric Adolescent AIDS Clinical Trials Group |
2004-02 | PHASE2; PHASE3 |
| NCT00302341 | TERMINATED | Pneumonia, Interstitial Plasma Cell; Pneumocystis Carinii Pneumonia; Pneumonia, Pneumocystis Carinii; HIV Infections |
Immtech Pharmaceuticals, Inc |
2006-05 | PHASE3 |
| NCT00679302 | COMPLETED | Skin Diseases, Infectious |
St. Louis University |
2006-07 | PHASE4 |
| NCT00061945 | COMPLETED | Acute Undifferentiated Leukemia; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; L1 Adult Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Adult Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
2003-06 | PHASE1; PHASE2 |
| NCT00324922 | COMPLETED | Osteomyelitis; Methicillin-resistant Staphylococcus Aureus |
University of Washington |
2006-05-01 | PHASE3 |
| NCT00870298 | TERMINATED | Prescribers' Drug Orders |
University of Pennsylvania |
2006-08 | |
| NCT00141037 | COMPLETED | Kidney Diseases; Kidney Transplantation; Kidney Transplant; Renal Transplantation; Renal Transplant |
National Institute of Allergy and Infectious Diseases (NIAID) |
2004-03 | PHASE1; PHASE2 |
| NCT00200616 | COMPLETED | Urinary Tract Infection |
Nantes University Hospital |
2001-04 | |
| NCT00189098 | COMPLETED | Chronic Otitis Media |
UMC Utrecht |
2003-02 | |
| NCT00002524 | COMPLETED | Lymphoma |
M.D. Anderson Cancer Center |
1993-06 | PHASE2 |
| NCT00014911 | COMPLETED | Diabetes Mellitus, Insulin-Dependent |
National Institute of Allergy and Infectious Diseases (NIAID) |
2001-04 | PHASE2 |
| NCT00791505 | COMPLETED | Chronic Obstructive Pulmonary Disease; Sepsis; Antibiotics |
University of Monastir |
2002-07 | PHASE3 |
| NCT00002571 | COMPLETED | Lymphoma |
SWOG Cancer Research Network |
1994-06 | PHASE2 |
| NCT00382343 | COMPLETED | Pyelonephritis; Renal Scars |
IRCCS Burlo Garofolo |
1999-11 | PHASE4 |
| NCT00168532 | COMPLETED | Post-Measles Pneumonia; Measles |
Bandim Health Project |
1998-01 | PHASE3 |
| NCT00000655 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000727 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00001027 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002283 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Jacobus Pharmaceutical |
||
| NCT00000826 | COMPLETED | Bacterial Infections; Mycoses; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002120 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
U.S. Bioscience |
PHASE1 | |
| NCT00002056 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
LyphoMed |
||
| NCT01101412 | WITHDRAWN | Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Unspecified Adult Solid Tumor, Protocol Specific |
M.D. Anderson Cancer Center |
PHASE1; PHASE2 | |
| NCT00000640 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00002002 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Lederle Laboratories |
||
| NCT00001990 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
||
| NCT00367081 | COMPLETED | Toxoplasmic Encephalitis; AIDS |
Department of Medical Services Ministry of Public Health of Thailand |
2003-05 | PHASE4 |
| NCT00789464 | WITHDRAWN | Recurrent Urinary Tract Infection |
Baylor College of Medicine |
PHASE2 | |
| NCT00000732 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00000816 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE4 | |
| NCT00000748 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00428818 | COMPLETED | Infection |
University of Texas Southwestern Medical Center |
2005-08 | |
| NCT00000730 | TERMINATED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00000734 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00000991 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00126698 | COMPLETED | Urinary Tract Infection; Bacteriuria |
St. Antonius Hospital |
2005-01 | PHASE4 |
| NCT00001996 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
PHASE2 | |
| NCT00004216 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Vion Pharmaceuticals |
1999-08 | PHASE1 |
| NCT00001013 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00137657 | COMPLETED | HIV; Malaria; Diarrhea; Pneumonia; Opportunistic Infections |
Centers for Disease Control and Prevention |
2002-02 | PHASE4 |
| NCT00001014 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00000715 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00000811 | COMPLETED | Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-03-20)
Check the
Sulfamethoxazole
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
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Note: Technical data last updated: Sep 1, 2026.