Clinical Trials

Numerous clinical trials, spanning Early Phase 1 through Phase 4, evaluate the therapeutic efficacy of levofloxacin across diverse indications. Sponsored by pharmaceutical corporations such as Sanofi and GlaxoSmithKline alongside academic centers like Shandong University and The First Hospital of Jilin University, research targets infectious diseases—including Helicobacter pylori, pneumonia, prostatitis, and resistant bacterial strains—and non-infectious conditions like acute ischemic stroke and cataract management. Across these studies, recruitment statuses vary from active recruitment and completion to withdrawal or termination.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07675954 NOT_YET_RECRUITING
Rifampicin-Resistant Tuberculosis
Seoul National University Hospital
2026-10-01 PHASE3
NCT06810583 RECRUITING
Leukemia; Acute Myeloid Leukemia; Lymphoblastic Leukemia in Children
St. Jude Children's Research Hospital
2025-05-22 PHASE1
NCT07585461 NOT_YET_RECRUITING
Opportunistic Infections, HIV Related; Disseminated Mycobacterium Avium Complex Infection
Shanghai Public Health Clinical Center
2026-04-30
NCT07788404 RECRUITING
Prosthetic Joint Infection; Osteomyelitis; Staphylococcal Infections
Groupe Hospitalier Diaconesses Croix Saint-Simon
2023-06-10
NCT06494072 RECRUITING
Community Acquired Pneumonia in Children
Medical College of Wisconsin
2024-08-22 PHASE4
NCT07528417 NOT_YET_RECRUITING
Myeldysplastic Syndrome (MDS); MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET); Acute Myeloid Leukemia
University of Manitoba
2026-09-01 PHASE2
NCT07240077 RECRUITING
Bacteremia; Streptococcus Infection
Mahidol University
2026-01-08 PHASE4
NCT07624422 NOT_YET_RECRUITING
Helicobacter Pylori Infection; Peptic Ulcer Disease; Gastritis
Damascus Hospital
2026-11-01 PHASE4
NCT07779629 NOT_YET_RECRUITING
Brucellosis; Osteoarthritis
The First Affiliated Hospital of Shihezi University
2026-09-01
NCT07126639 NOT_YET_RECRUITING
Efficacy and Safety
Wuhan Pulmonary Hospital
2025-09-01
NCT07198685 NOT_YET_RECRUITING
Treat to Target; Treatment Duration
Wuhan Pulmonary Hospital
2025-09-30
NCT06568484 RECRUITING
Tuberculosis, Latent
Johns Hopkins University
2026-05-08 PHASE2; PHASE3
NCT03828201 ACTIVE_NOT_RECRUITING
Tuberculosis, Multidrug-Resistant
Boston University
2022-06-07 PHASE2
NCT06498414 RECRUITING
Tuberculosis Infection, Latent
McGill University Health Centre/Research Institute of the McGill University Health Centre
2025-06-10 PHASE2; PHASE3
NCT06172010 RECRUITING
Prosthetic-joint Infection; Infection Hip; Infection; Knee, Joint
Leiden University Medical Center
2023-04-01 PHASE4
NCT06649721 ACTIVE_NOT_RECRUITING
Drug-resistant Tuberculosis; Pulmonary Tuberculosis; Rifampin-resistant Tuberculosis
Huashan Hospital
2024-11-27 PHASE3
NCT06065267 NOT_YET_RECRUITING
Helicobacter Pylori Infection
Damascus Hospital
2024-01-02 PHASE4
NCT06977347 NOT_YET_RECRUITING
Severe Community-acquired Pneumonia (sCAP)
CHOSEOK YOON
2025-06-15
NCT05398679 RECRUITING
Endocarditis Infective
Fundacion Clinic per a la Recerca Biomédica
2022-08-17 PHASE4
NCT07696819 NOT_YET_RECRUITING
Surgical Site Infection (SSI)
Sylhet M.A.G.Osmani Medical College
2026-08-01
NCT07069582 NOT_YET_RECRUITING
Tuberculosis Infection; Healthy Volunteer; Breastfeeding
McGill University Health Centre/Research Institute of the McGill University Health Centre
2026-04-01 PHASE1
NCT07574983 NOT_YET_RECRUITING
HELICOBACTER PYLORI INFECTIONS
University of Health Sciences Lahore
2026-06-01
NCT06081361 ACTIVE_NOT_RECRUITING
Pulmonary Tuberculosis; Rifampicin-resistant Tuberculosis
Beijing Chest Hospital
2023-12-22 PHASE3
NCT06200779 NOT_YET_RECRUITING
Helicobacter Pylori Infection
Manuel Coelho da Rocha
2025-09 PHASE4
NCT07179159 RECRUITING
HELICOBACTER PYLORI INFECTIONS
Yanqing Li
2025-09-09
NCT07320534 NOT_YET_RECRUITING
Neutropenic Fever; Acute Lymphoblastic Leukemia
Gadjah Mada University
2026-01-01 PHASE4
NCT06741917 UNKNOWN
Retrograde Intrarenal Surgery; Renal Stones
National Taiwan University Hospital
2024-12-04 PHASE4
NCT05061732 UNKNOWN
Helicobacter Pylori Infection
Shanghai Zhongshan Hospital
2021-09-30 PHASE4
NCT06209047 RECRUITING
Bronchiectasis With Acute Exacerbation
Assiut University
2023-10-15 PHASE4
NCT06787885 COMPLETED
Empyema, Pleural
Fayoum University
2024-05-01
NCT07344506 RECRUITING
H. Pylori Gastrointestinal Disease; H.Pylori Infection; H.Pylori Eradication Rate
Dow University of Health Sciences
2025-05-01 PHASE4
NCT05743101 UNKNOWN
Acute Ischemic Stroke
Yi Yang
2025-05-01
NCT07021729 NOT_YET_RECRUITING
Helicobacter Pylori Infection
Rehman Medical Institute - RMI
2025-12 PHASE4
NCT02735707 RECRUITING
Community-acquired Pneumonia, Influenza, COVID-19
UMC Utrecht
2016-04-11 PHASE3
NCT07040839 NOT_YET_RECRUITING
H Pylori
Rehman Medical Institute - RMI
2025-07 PHASE4
NCT06049758 NOT_YET_RECRUITING
Blood Loss; Intensive Care; Anastomotic Leakage; Lymph Node Disease; Survival; Blood Transfusion
General Committee of Teaching Hospitals and Institutes, Egypt
2024-01-02
NCT04951986 ACTIVE_NOT_RECRUITING
Disseminated Tuberculosis; HIV
University of Cape Town
2021-08-11 PHASE3
NCT06797544 RECRUITING
Cutaneous Leishmaniasis
Hayder Adnan Fawzi
2025-02-09 PHASE2
NCT05867654 UNKNOWN
Osteomyelitis of Jaw
University of Louisville
2024-07-31 PHASE4
NCT06650540 NOT_YET_RECRUITING
IVF
Peking University Third Hospital
2024-10-22
NCT06859450 NOT_YET_RECRUITING
Community Acquired Pneumonia (CAP)
Copenhagen Respiratory Research
2025-03-04 PHASE2; PHASE3
NCT05306223 UNKNOWN
Tuberculosis, Multidrug-Resistant
Beijing Chest Hospital
2022-05-10 PHASE4
NCT07150065 COMPLETED
Typhoid; Fever
Avicenna Medical College Lahore
2025-02-07 PHASE2
NCT06915688 NOT_YET_RECRUITING
COPD
Amina Aslam
2025-04-15
NCT06571097 UNKNOWN
Constipation
Haifeng Lan
2024-07-01
NCT07150286 COMPLETED
Immune Thrombocytopenic Purpura; HELICOBACTER PYLORI INFECTIONS
Al-Mustansiriyah University
2024-09-01
NCT05393505 UNKNOWN
Neutropenic Fever
The University of Hong Kong
2022-10-24 PHASE4
NCT04502095 COMPLETED
Bladder Carcinoma; Refractory Bladder Carcinoma; Urinary Tract Infection
Roswell Park Cancer Institute
2020-09-02 PHASE4
NCT05977868 TERMINATED
Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection
West Virginia University
2023-08-04 PHASE4
NCT05741905 RECRUITING
Acute Ischemic Stroke
Yi Yang
2023-06-01
NCT07229755 COMPLETED
Urinary Tract Infection (Diagnosis)
Ain Shams University
2024-07-01 PHASE2; PHASE3
NCT05850117 UNKNOWN
Helicobacter Pylori Eradication
Kaohsiung Medical University
2020-02-10
NCT05799326 RECRUITING
Acute Ischemic Stroke
Yi Yang
2023-06-30
NCT05302531 UNKNOWN
Short Bowel Syndrome; Infection, Bacterial
Central Hospital, Nancy, France
2022-12-09 PHASE1
NCT06351891 UNKNOWN
Helicobacter Pylori Infection
Qilu Hospital of Shandong University
2024-04 PHASE4
NCT05156437 TERMINATED
Endocarditis
West Virginia University
2022-03-16 PHASE4
NCT06710977 COMPLETED
Cataract
Tan Tock Seng Hospital
2022-01-01 EARLY_PHASE1
NCT03850379 COMPLETED
Prophylaxis; Stem Cell Transplant Complications
Henry Ford Health System
2018-03-14 PHASE2
NCT02701608 COMPLETED
Infective Endocarditis
University Hospital, Tours
2016-02-29 PHASE3
NCT06684626 COMPLETED
Prostate Inflammation; Prostate Disease; Chronic Bacterial Prostatitis
Federico II University
2024-03-01 PHASE3
NCT03594149 COMPLETED
Myelodysplastic Syndromes; Acute Myeloid Leukemia
Centre Henri Becquerel
2018-07-18 PHASE3
NCT07355907 COMPLETED
Calculi, Renal; PCNL; Infectious Complications
Tanta University
2023-01-01
NCT05575427 UNKNOWN
Hospital Infections
Mahidol University
2022-11-24 PHASE4
NCT04062201 COMPLETED
Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis
Wits Health Consortium (Pty) Ltd
2019-08-22 PHASE3
NCT05079620 TERMINATED
Aspiration; Aspiration Pneumonia
UConn Health
2021-11-30 PHASE4
NCT06414707 COMPLETED
Helicobacter Pylori Infection
Ain Shams University
2023-10-12 PHASE3
NCT05743101 Not yet recruiting
Acute Ischemic Stroke
Yi Yang|The First Hospital of Jilin University
2024-04-01 Not Applicable
NCT06017479 COMPLETED
Urological System Complication of Procedure; Urinary Tract Infections
Indonesia University
2022-12-30 PHASE1; PHASE2
NCT03087656 UNKNOWN
Cholangitis
University of Southern California
2017-03-29 PHASE4
NCT06088316 UNKNOWN
Helicobacter Pylori Infection; Helicobacter Pylori Eradication
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2023-02-10 PHASE4
NCT05549115 UNKNOWN
Helicobacter Pylori Infection
Liaocheng People's Hospital
2022-09-20
NCT04626193 UNKNOWN
Helicobacter Pylori Infection
Damascus Hospital
2020-10-31 PHASE4
NCT05313750 UNKNOWN
Acute Exacerbation of Bronchiectasis
Shanghai Pulmonary Hospital, Shanghai, China
2021-06-30 PHASE4
NCT05441930 WITHDRAWN
Cataract
PolyActiva Pty Ltd
2023-06-23 PHASE1
NCT06616922 COMPLETED
Conjunctivitis, Bacterial
NTC srl
2021-11-05 PHASE2
NCT05799326 Recruiting
Acute Ischemic Stroke
Yi Yang|The First Hospital of Jilin University
2023-06-30 Not Applicable
NCT05741905 Recruiting
Acute Ischemic Stroke
Yi Yang|The First Hospital of Jilin University
2023-06-01 Not Applicable
NCT05441930 Withdrawn
Cataract
PolyActiva Pty Ltd
2023-06-23 Phase 1
NCT02754765 COMPLETED
Tuberculosis, Multidrug-Resistant; Infection, Bacterial; Pulmonary Tuberculoses
Médecins Sans Frontières, France
2016-12 PHASE3
NCT04359966 UNKNOWN
Helicobacter Pylori Infection; Eradication Treatments
Slovenian Society for Gastroenterology and Hepatology
2020-05-10
NCT06199778 TERMINATED
Traumatic Brain Injury
Zeng Changhao
2022-06-01
NCT05728424 UNKNOWN
Helicobacter Pylori Infection
Aga Khan University
2022-09-20 PHASE3
NCT05741632 COMPLETED
Cataract
Indonesia University
2023-02-01 PHASE1
NCT03257423 UNKNOWN
Acute Appendicitis
Turku University Hospital
2017-04-04
NCT05023577 UNKNOWN
Helicobacter Pylori Infection
Shanghai Zhongshan Hospital
2021-08-26 PHASE4
NCT05250050 WITHDRAWN
Helicobacter Pylori Infection
Shanghai Zhongshan Hospital
2022-03-25 PHASE4
NCT02621359 UNKNOWN
Dyspepsia
Tanta University
2015-01 PHASE3
NCT04122287 UNKNOWN
Helicobacter Pylori Infection
Shandong University
2019-11-01 PHASE4
NCT04204382 UNKNOWN
Radiation-induced Oral Mucositis
Shanxi Zhendong Pharmacy Co., Ltd
2019-12-12 PHASE4
NCT03098485 COMPLETED
Microbiota; Anti-bacterial Agents
Washington University School of Medicine
2017-01
NCT02981615 COMPLETED
Prevention
Sheba Medical Center
2017-08-01 PHASE3
NCT05129176 UNKNOWN
Helicobacter Pylori Infection
Shandong University
2021-11-23 PHASE4
NCT05126121 UNKNOWN
Helicobacter Pylori Infection
Xiuli Zuo
2021-11-20
NCT04991584 UNKNOWN
Helicobacter Pylori Infection
Shandong University
2021-08-04
NCT02409290 COMPLETED
MDR-TB
IUATLD, Inc
2016-03 PHASE3
NCT05219877 COMPLETED
Urinary Tract Infections
Indonesia University
2022-02-04 PHASE1; PHASE2
NCT01918397 COMPLETED
Tuberculosis, Multidrug-Resistant
Boston University
2015-01 PHASE2
NCT03474198 COMPLETED
Tuberculosis, Pulmonary
University College, London
2018-03-21 PHASE2; PHASE3
NCT04212078 UNKNOWN
Endophthalmitis Postoperative
National University of Malaysia
2019-07-29 PHASE1; PHASE2
NCT03021590 WITHDRAWN
Helicobacter Pylori Gastrointestinal Tract Infection
Damascus Hospital
2017-06-01 PHASE4
NCT03779074 COMPLETED
Helicobacter Pylori Infection
Kaohsiung Veterans General Hospital.
2018-09-03 PHASE3
NCT05863858 COMPLETED
Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to
Iyad Naeem Muhammad, PhD
2020-06-01 PHASE3
NCT04682288 COMPLETED
Cataract
PolyActiva Pty Ltd
2021-01-04 PHASE1
NCT03555526 UNKNOWN
H Pylori Infection
National Taiwan University Hospital
2017-12-15 PHASE4
NCT04374188 UNKNOWN
Nephrolithiasis
Diaa Eldin Taha Ramadan Mohamed
2019-09-01
NCT02975570 WITHDRAWN
Tuberculosis Multi Drug Resistant Active
Boston University
2017-08 PHASE3
NCT04212429 UNKNOWN
Endophthalmitis Postoperative
National University of Malaysia
2019-09-23 PHASE1; PHASE2
NCT04214821 UNKNOWN
Endophthalmitis
National University of Malaysia
2019-09-23 PHASE1; PHASE2
NCT02619994 COMPLETED
Tuberculosis, Multidrug-Resistant
Seoul National University Hospital
2016-01 PHASE2
NCT04432233 UNKNOWN
Helicobacter Pylori Infection; Intravenous Drug Usage
Shanghai Jiao Tong University School of Medicine
2020-06-15 PHASE4
NCT02809131 COMPLETED
Sick Sinus Syndrome; Complete Heart Block; Syncope; Chronic Systolic Heart Failure
Vanderbilt University Medical Center
2016-04-01 PHASE3
NCT04107194 UNKNOWN
Helicobacter Pylori Infection; Antibiotic Resistant Infection; Antibiotic Resistant Strain
University of Bari
2020-01-14 PHASE3
NCT03673956 COMPLETED
Chronic Rhinosinusitis (Diagnosis)
Mayo Clinic
2018-09-26 PHASE1; PHASE2
NCT03698682 COMPLETED
Chronic Obstructive Pulmonary Disease
University of Monastir
2018-01-01 PHASE2
NCT02454205 COMPLETED
Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis
University of Cape Town
2015-11-12 PHASE2; PHASE3
NCT02618057 UNKNOWN
Mycoplasma Pneumoniae Pneumonia
Seoul National University Hospital
2016-06 PHASE4
NCT02958709 COMPLETED
Tuberculosis, Meningeal
Johns Hopkins University
2017-02-22 PHASE1; PHASE2
NCT02717871 COMPLETED
Keratitis; Infectious Disease (Manifestation)
University Hospital, Geneva
2016-03 PHASE3
NCT04348786 COMPLETED
Helicobacter Pylori Infection
Damascus Hospital
2019-02-01 PHASE4
NCT03832465 COMPLETED
Helicobacter Pylori Infection
Mackay Memorial Hospital
2019-06-14 PHASE4
NCT03613389 UNKNOWN
Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Cairo University
2020-01-01
NCT03201796 COMPLETED
Chronic Bacterial Prostatitis
Aziende Chimiche Riunite Angelini Francesco S.p.A
2016-02-02 PHASE2
NCT02800785 COMPLETED
Appendicitis
University of Washington
2016-05
NCT04090021 UNKNOWN
Helicobacter Pylori Infection
Konstantopoulio-Patission General Hospital of Nea Ionia
2019-09-01 PHASE4
NCT03658746 COMPLETED
Helicobacter Pylori Infection
Shandong University
2019-01-01 PHASE4
NCT03571230 UNKNOWN
Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing
Shandong University
2018-07-01 PHASE4
NCT04212403 COMPLETED
Urosepsis; Bladder Cancer; Prostate Hyperplasia; Antibiotic Resistant Strain; Antibiotic Resistant Infection; Antibiotic-associated Diarrhea; Antibiotic Toxicity
Jessa Hospital
2018-09-17
NCT02789579 UNKNOWN
Complication of Surgical Procedure
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2016-09 EARLY_PHASE1
NCT03148366 COMPLETED
Helicobacter
National Taiwan University Hospital
2015-02 PHASE3
NCT03697993 TERMINATED
Urinary Tract Infection
National Institute of Allergy and Infectious Diseases (NIAID)
2018-11-07 PHASE4
NCT03708848 COMPLETED
Helicobacter Pylori Infection
Shanghai Jiao Tong University School of Medicine
2018-12-05 PHASE4
NCT03159845 COMPLETED
Stem Cell Transplant Complications
Azienda Ospedaliero, Universitaria Pisana
2014-01-01 PHASE2
NCT03472144 UNKNOWN
Chronic Sinusitis, Ethmoidal; Chronic Sinusitis - Ethmoidal Anterior; Chronic Sinusitis; Chronic Sinusitis - Ethmoidal, Posterior; Chronic Sinusitis, Sphenoidal; Chronic Sinusitis - Frontoethmoidal; Nasal Polyps; Nasal Polyp - Posterior
LifeBridge Health
2017-07-07 PHASE3
NCT03658291 UNKNOWN
Urinary Tract Infection Lower Acute
China Academy of Chinese Medical Sciences
2019-01-01 PHASE4
NCT03757234 COMPLETED
Acute Pyelonephritis
Paratek Pharmaceuticals Inc
2018-11-19 PHASE2
NCT02024555 COMPLETED
Sarcoidosis; Antimycobacterial Therapy
Vanderbilt University
2014-03 PHASE2
NCT02067780 COMPLETED
Chronic Obstructive Pulmonary Disease
University of Monastir
2017-05-01 PHASE3
NCT04039412 COMPLETED
Helicobacter Pylori Infection
Ayman Magd Eldin Mohammad Sadek
2018-06-01 PHASE4
NCT03739528 COMPLETED
Cataract
NTC srl
2018-09-03 PHASE3
NCT03740659 COMPLETED
Cataract
NTC srl
2018-09-04 PHASE2
NCT03003273 TERMINATED
Neutropenia, Febrile; Pediatric Cancer
All India Institute of Medical Sciences
2017-01 PHASE3
NCT02901288 UNKNOWN
Tuberculosis, Pulmonary
Beijing Chest Hospital
2016-08 PHASE4
NCT03391440 UNKNOWN
Pelvic Inflammatory Disease
Jiangsu Hansoh Pharmaceutical Co., Ltd.
2016-09 PHASE4
NCT02422706 UNKNOWN
Helicobacter-associated Gastritis
Sherief Abd-Elsalam
2015-01 PHASE3
NCT04456712 COMPLETED
QTc Prolongation, Hyperglycemia, Hypoglycemia
Beni-Suef University
2018-06-01 PHASE4
NCT04352062 COMPLETED
Melatonin Deficiency
Medical University of Lodz
2011-01-09
NCT03413020 COMPLETED
Helicobacter Pylori Infection
Shanghai Jiao Tong University School of Medicine
2018-01-03 PHASE4
NCT03397680 UNKNOWN
Helicobacter Pylori Infection
Thammasat University
2017-05-15 PHASE1
NCT04403334 COMPLETED
Cataract Senile; Endophthalmitis; Antibiotic Side Effect; Safety Issues
Peregrine Eye and Laser Institute
2018-01-02 PHASE4
NCT02741414 UNKNOWN
Gastritis
Taizhou Hospital
2016-06
NCT02757365 UNKNOWN
Prostate Cancer
West China Hospital
2014-04 PHASE4
NCT02789865 UNKNOWN
Acute Appendicitis
First Affiliated Hospital Xi'an Jiaotong University
2016-05 PHASE2
NCT02935010 COMPLETED
Helicobacter Pylori Infection
Shanghai Jiao Tong University School of Medicine
2017-02-05 PHASE4
NCT03160807 UNKNOWN
Urinary Tract Infection
Dr. Reddy's Laboratories Limited
2017-04-15 PHASE4
NCT03087162 COMPLETED
H Pylori Eradication
Ramathibodi Hospital
2017-01-01 PHASE4
NCT03038321 UNKNOWN
Non-Muscle-invasive Bladder Cancer (NMIBC); Bacillus Calmette-Guerin (BCG) Cystitis; Intra-vesical Instillation
Mansoura University
2017-02-01 PHASE4
NCT03032510 COMPLETED
Complicated Urinary Tract Infections
Tetraphase Pharmaceuticals, Inc
2017-01 PHASE3
NCT01988779 COMPLETED
Chronic Rhinosinusitis
University of Rochester
2013-10 PHASE3
NCT02978157 COMPLETED
Helicobacter Pylori Infection
Kaohsiung Veterans General Hospital.
2015-02
NCT02988089 UNKNOWN
Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing
Shandong University
2017-04-20 PHASE4
NCT03139253 UNKNOWN
Antimicrobial Susceptibility Testing; Triple Therapy
Yanqing Li
2017-05-30 PHASE4
NCT03178292 UNKNOWN
Percutaneous Nephrolithotomy; Infection; Sepsis; Antibiotics
Mansoura University
2017-06-15
NCT03138785 UNKNOWN
Treatment
Farabi Eye Hospital
2015-01-01
NCT01371656 COMPLETED
Acute Leukemias of Ambiguous Lineage; Bacterial Infection; Diarrhea; Fungal Infection; Musculoskeletal Complications; Neutropenia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Children's Oncology Group
2011-09 PHASE3
NCT02205112 COMPLETED
Community-acquired Pneumonia
TaiGen Biotechnology Co., Ltd.
2014-06 PHASE3
NCT02573610 COMPLETED
Cataract Surgery
Santen Pharmaceutical Co., Ltd.
2015-09-21 PHASE3
NCT02693574 UNKNOWN
Helicobacter Pylori Gastrointestinal Tract Infection
Damascus Hospital
2015-12-01 PHASE4
NCT02486627 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis
Achaogen, Inc.
2016-01-11 PHASE3
NCT02466919 COMPLETED
Helicobacter Pylori Infection
Chung-Tai Wu
2014-05 PHASE4
NCT02166476 COMPLETED
Urinary Tract Infection Complicated; Acute Pyelonephritis
Melinta Therapeutics, Inc.
2014-11-20 PHASE3
NCT02600806 UNKNOWN
Community-acquired Pneumonia
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
2005-05 PHASE4
NCT01618591 TERMINATED
Acute Watery Diarrhea; Dysentery/Febrile Diarrhea
Uniformed Services University of the Health Sciences
2012-09
NCT01537055 UNKNOWN
Eradication Rate for Helicobacter
National Taiwan University Hospital
2012-02 PHASE4
NCT02596620 COMPLETED
Helicobacter Pylori Infection
Chang Gung Memorial Hospital
2013-10
NCT01978938 COMPLETED
cUTI
Tetraphase Pharmaceuticals, Inc
2014-10-06 PHASE3
NCT02439632 COMPLETED
Acute Lower Urinary Tract Infection
Lee's Pharmaceutical Limited
2014-02 PHASE3
NCT02094703 UNKNOWN
Urinary Tract Infection
Dr Cipto Mangunkusumo General Hospital
2013-04 PHASE4
NCT01875263 TERMINATED
Staphylococcus
Fundación Pública Andaluza Progreso y Salud
2013-05 PHASE3
NCT02018081 COMPLETED
Intensive Care Unit Syndrome; Community-acquired Pneumonia
University Hospital, Toulouse
2012-03 PHASE4
NCT02699658 COMPLETED
Healthy Volunteers
Prince of Songkla University
2013-10 PHASE2
NCT02212795 COMPLETED
Healthy
Dong Wha Pharmaceutical Co. Ltd.
2014-05 PHASE1
NCT02157571 UNKNOWN
Acute Exacerbations of Chronic Bronchitis
Lee's Pharmaceutical Limited
2013-06 PHASE3
NCT02148016 UNKNOWN
Corneal Disease; Pterygium; Myopia; Hyperopia
Sun Yat-sen University
2012-12 PHASE1; PHASE2
NCT01524302 COMPLETED
Pneumonia, Bacterial; Community-acquired
Gary E. Stein, Pharm.D.
2012-02 PHASE4
NCT02884713 COMPLETED
GASTRITIS
King Faisal Specialist Hospital & Research Center
2013-06
NCT02726269 COMPLETED
Helicobacter Pylori Gastritis
Asofarma de México S.A de C.V.
2012-06 PHASE3
NCT01353339 COMPLETED
Disease Due to BK Polyomavirus; Kidney Transplant Infection
Ottawa Hospital Research Institute
2011-12-01 PHASE4
NCT01761201 TERMINATED
Latent Tuberculosis Infection; Infection in Solid Organ Transplant Recipients
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
2012-01 PHASE3
NCT01109823 COMPLETED
Infection
University Ghent
2010-05-19 PHASE3
NCT02128308 COMPLETED
Healthy
Seoul National University Hospital
2013-11 PHASE1
NCT01710488 COMPLETED
COPD Exacerbation
Fadoi Foundation, Italy
2009-05 PHASE4
NCT01345929 COMPLETED
Complicated Urinary Tract Infection; Pyelonephritis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2011-06-20 PHASE3
NCT01163435 COMPLETED
Helicobacter Infection
National Taiwan University Hospital
2010-08 PHASE4
NCT02028754 COMPLETED
Dry Eye Syndromes; Cataract
Allergan
2011-07 PHASE4
NCT01742429 COMPLETED
Cure Rate of Helicobacter Pylori Infection
Shanghai Jiao Tong University School of Medicine
2012-11 PHASE4
NCT01270347 COMPLETED
Cystic Fibrosis
Amgen
2011-01 PHASE3
NCT01667718 COMPLETED
Functional Dyspepsia; Peptic Ulcer
Shanghai Jiao Tong University School of Medicine
2012-05 PHASE4
NCT01529476 COMPLETED
Pneumonia
TaiGen Biotechnology Co., Ltd.
2011-04 PHASE3
NCT05339295 COMPLETED
Healthy; Pharmacokintetics
University of Karachi
2012-07-11 PHASE1
NCT01055145 TERMINATED
TB
Seoul National University Hospital
2010-03 PHASE3
NCT01467297 COMPLETED
COPD Exacerbation
University of Milan
2012-01 PHASE4
NCT01034176 COMPLETED
BK Viremia
Brigham and Women's Hospital
2009-02 PHASE4
NCT01180634 COMPLETED
Cystic Fibrosis
Amgen
2010-11-04 PHASE3
NCT01096849 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis
Achaogen, Inc.
2010-07-13 PHASE2
NCT01081964 TERMINATED
Community Acquired Pneumonia
IASO Pharma Inc.
2010-03 PHASE2
NCT01500837 COMPLETED
Osteoarticular Infection
Assistance Publique - Hôpitaux de Paris
2010-10
NCT00789997 COMPLETED
COPD Exacerbation
Ottawa Hospital Research Institute
2008-11 PHASE2; PHASE3
NCT01131026 COMPLETED
Helicobacter Pylori Infection
Deva Holding A.S.
2010-06 PHASE3
NCT00873626 COMPLETED
Urinary Tract Infection; Fever
Assistance Publique - Hôpitaux de Paris
2009-06 PHASE4
NCT01168713 COMPLETED
Community-Acquired Bacterial Pneumonia
Melinta Therapeutics, Inc.
2010-08 PHASE2
NCT01544517 COMPLETED
Helicobacter Pylori Infection
University of Campania Luigi Vanvitelli
2011-01 PHASE3
NCT01537250 COMPLETED
Community-acquired Pneumonia
TaiGen Biotechnology Co., Ltd.
2009-08 PHASE2
NCT00906048 TERMINATED
Infection
Sanofi
2009-04 PHASE3
NCT00752947 UNKNOWN
Community-Acquired Pneumonia
Beijing Hospital
2008-09 PHASE4
NCT00840333 COMPLETED
Cystic Fibrosis
Amgen
2009-04 PHASE1
NCT01575899 TERMINATED
Helicobacter Pylori Infection
Buddhist Tzu Chi General Hospital
2007-12 PHASE4
NCT00840580 COMPLETED
Cataract Extraction
Alcon Research
2009-01 PHASE4
NCT00816140 COMPLETED
Helicobacter Infections
National Taiwan University Hospital
2007-06 PHASE4
NCT00659646 COMPLETED
Diabetic Foot Ulcer
Innocoll
2008-04 PHASE2
NCT00593567 COMPLETED
Diabetic Foot Ulcer
Innocoll
2007-12 PHASE2
NCT00764582 TERMINATED
Corneal Transplantation
Santen Inc.
2008-09 PHASE4
NCT00250718 TERMINATED
Non-Hodgkin's Lymphoma; Cancer
New Mexico Cancer Research Alliance
2004-10 PHASE2
NCT00752414 COMPLETED
Chronic Obstructive Pulmonary Disease
Amgen
2008-07 PHASE1
NCT00630019 COMPLETED
Cataract
Santen Inc.
2008-02 PHASE4
NCT00362869 TERMINATED
Escherichia Coli Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2008-02 PHASE1
NCT00176306 COMPLETED
Obesity; Critical Illness
Joel Thompson, PhD
2005-01 PHASE4
NCT00703313 COMPLETED
Healthy
Santen Inc.
2008-05 PHASE4
NCT00453349 COMPLETED
Pelvic Inflammatory Disease
Bayer
2007-01 PHASE3
NCT00495339 COMPLETED
Tuberculosis, Pulmonary
Sanofi
2007-06 PHASE4
NCT00402688 COMPLETED
Prostatitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2006-11 PHASE3
NCT00503490 COMPLETED
Cystic Fibrosis
Amgen
2007-06 PHASE1
NCT00516958 COMPLETED
Foot Ulcer, Diabetic
Oculus Innovative Sciences, Inc.
2007-05 PHASE2
NCT00396084 COMPLETED
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
2004-02-10 PHASE1; PHASE2
NCT00253955 COMPLETED
Pneumonia
Sanofi
2003-06 PHASE3
NCT00169585 COMPLETED
Prostatic Hyperplasia; Prostatitis
GlaxoSmithKline
2005-03 PHASE3
NCT00079885 COMPLETED
Community Acquired Pneumonia; Bacterial Pneumonia; Cross Infection
Wyeth is now a wholly owned subsidiary of Pfizer
2003-11 PHASE3
NCT00431678 COMPLETED
Pneumonia
Bayer
2004-01 PHASE3
NCT00081575 COMPLETED
Community-Acquired Infections; Bacterial Pneumonia; Cross Infection
Wyeth is now a wholly owned subsidiary of Pfizer
2004-01 PHASE3
NCT00665327 COMPLETED
Pneumonia
Bayer
2002-11 PHASE4
NCT00645073 COMPLETED
Acute Bacterial Sinusitis
Abbott
2003-11 PHASE4
NCT00257036 COMPLETED
Skin Diseases, Infectious; Cellulitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1991-07 PHASE2; PHASE3
NCT00392275 COMPLETED
Cataract
Indiana University
2002-11 PHASE4
NCT00000796 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00643734 COMPLETED
Pneumonia
Pfizer
2003-04 PHASE3
NCT00643409 COMPLETED
Maxillary Sinusitis
Pfizer
2003-01 PHASE3
NCT00215007 UNKNOWN
Malignancy; Allogeneic Stem Cell Transplantation
Charite University, Berlin, Germany
PHASE2; PHASE3
NCT00136344 COMPLETED
Endophthalmitis
City, University of London
2003-09
NCT00249210 COMPLETED
Sinusitis; Maxillary Sinusitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1993-08 PHASE3
NCT00249197 COMPLETED
Skin Diseases, Bacterial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1997-01 PHASE3
NCT00034736 COMPLETED
Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-08 PHASE3
NCT00236522 COMPLETED
Sinusitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-10 PHASE3
NCT00491049 COMPLETED
Conjunctival Bacterial Flora
Ludwig-Maximilians - University of Munich
2004-09 PHASE4
NCT00002249 COMPLETED
HIV Infections
R W Johnson Pharmaceutical Research Institute
PHASE1
NCT00258089 COMPLETED
Urinary Tract Infections; Bacteriuria; Urologic Diseases; Pyelonephritis; Neurogenic Bladder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1993-06 PHASE3
NCT00005590 COMPLETED
Brain and Central Nervous System Tumors; Breast Cancer; Extragonadal Germ Cell Tumor; Infection; Lung Cancer; Lymphoma; Ovarian Cancer; Small Intestine Cancer; Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific
Cancer Research Campaign Clinical Trials Centre
1999-08 PHASE3
NCT00429975 TERMINATED
Pneumonia, Pneumococcal
Hospital Mutua de Terrassa
2004-08 PHASE4
NCT00001033 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00602589 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-10 PHASE1
NCT00821782 COMPLETED
Healthy Volunteer
Ortho-McNeil Janssen Scientific Affairs, LLC
2006-06 PHASE1
NCT00239161 TERMINATED
Acute Uncomplicated Pyelonephritis
University of Manitoba
2004-09 PHASE4
NCT00277511 COMPLETED
Prostatitis
Sanofi
2003-03 PHASE3
NCT00236834 COMPLETED
Nosocomial Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1997-12 PHASE3
NCT00257049 COMPLETED
Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1984-01 PHASE2; PHASE3
NCT00645437 COMPLETED
Renal Diseases
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2004-10 PHASE1
NCT00269932 COMPLETED
Bronchitis, Chronic
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1993-08 PHASE3
NCT00644449 COMPLETED
Bronchitis, Chronic
Pfizer
2003-01 PHASE3
NCT00000778 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE1
NCT00565123 COMPLETED
Bacterial Conjunctivitis
Laser Microsurgery Centre, Poland
2004-09 PHASE2; PHASE3
NCT00051753 COMPLETED
Otitis Media
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-11 PHASE3
NCT00601432 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-10 PHASE1
NCT00236821 COMPLETED
Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2001-03 PHASE3
NCT00236912 TERMINATED
Appendicitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2003-07 PHASE4
NCT00236808 COMPLETED
Prostatitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2000-05 PHASE3
NCT00376376 COMPLETED
Healthy Volunteers
Michigan State University
2006-09
NCT00210886 COMPLETED
Urinary Tract Infections; Pyelonephritis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2004-10 PHASE3
NCT00245791 TERMINATED
Complicated Urinary Infection
University of Manitoba
2004-10 PHASE4
NCT00258102 COMPLETED
Urinary Tract Infections; Bacterial Infections; Bacteriuria; Urologic Diseases
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1993-01 PHASE3
NCT00257140 COMPLETED
Bronchitis; Bronchitis, Chronic
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1931-06 PHASE2; PHASE3
NCT00257062 COMPLETED
Skin Diseases, Infectious
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1993-01 PHASE3
NCT00042718 COMPLETED
Bronchitis; Chronic Bronchitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2001-11 PHASE3
NCT00044473 COMPLETED
Otitis Media
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2002-11 PHASE3
NCT00236652 COMPLETED
Maxillary Sinusitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2003-11 PHASE3
NCT00035347 COMPLETED
Community-Acquired Pneumonia (CAP)
Pfizer
2001-01 PHASE4
NCT00020865 UNKNOWN
Fever, Sweats, and Hot Flashes; Infection; Leukemia; Lymphoma; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
Jonsson Comprehensive Cancer Center
2001-09 PHASE3
NCT00164112 COMPLETED
Healthy
Bassett Healthcare
2004-11 PHASE4
NCT00434291 COMPLETED
Community-Acquired Pneumonia
TaiGen Biotechnology Co., Ltd.
2006-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-30)

Check the Levofloxacin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levofloxacin selectively binds to bacterial type II topoisomerases, specifically DNA gyrase and topoisomerase IV, where it inhibits the A subunits to disrupt DNA supercoiling and induce double-stranded chromosome breakage. This inhibition halts bacterial DNA replication and transcription, ultimately leading to bactericidal activity against pathogens evaluated in clinical studies for conditions such as Helicobacter pylori infection, pneumonia, and antibiotic-resistant bacterial infections.

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.