Numerous clinical trials evaluate the therapeutic utility and pharmacokinetic profiles of meropenem across diverse indications, including severe bacterial infections, hospital-acquired pneumonia, febrile neutropenia, melioidosis, septic shock, and post-cardiac surgery or ECMO complications. Spanning Phase 1 through Phase 4, early feasibility, and non-applicable phase designations, these studies are sponsored by academic medical centers and health organizations such as University Hospital Grenoble, Wake Forest University Health Sciences, and Oslo University Hospital. The trials reflect various recruitment statuses, including recruiting, completed, terminated, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07759453 | NOT_YET_RECRUITING | Liver Transplant; Carbapenem-resistant Enterobacterales; CRE Colonization |
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
2026-10-01 | PHASE3 |
| NCT07004049 | RECRUITING | Bloodstream Infection; Ventilator Associated Bacterial Pneumonia; Hospital Acquired Bacterial Pneumonia; Carbapenem Resistant Bacterial Infection; Multidrug Resistance |
National University of Singapore |
2025-04-21 | PHASE4 |
| NCT06184659 | RECRUITING | Sepsis; Septic Shock |
Scandinavian Critical Care Trials Group |
2025-06-26 | PHASE4 |
| NCT07556107 | RECRUITING | Infection; Acute Kidney Injury; Sepsis |
Bassett Healthcare |
2026-08-17 | PHASE4 |
| NCT07327619 | RECRUITING | Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia |
Qilu Pharmaceutical Co., Ltd. |
2026-01-22 | PHASE3 |
| NCT07484633 | NOT_YET_RECRUITING | Infection; Sepsis; NICU; PICU; Beta Lactams |
Semmelweis University |
2026-04 | PHASE4 |
| NCT05925309 | RECRUITING | Biliary Atresia; Cholangitis; Anti-Bacterial Agents |
Children's Hospital of Fudan University |
2023-07-01 | |
| NCT07326540 | RECRUITING | Hospital Acquired Bacterial Pneumonia (HABP); Ventilator Associated Bacterial Pneumonia (VABP); Colistin Resistanrt ABC; Acinetobacter Baumannii-calcoaceticus Complex |
BioVersys SAS |
2026-03-27 | PHASE3 |
| NCT07512596 | RECRUITING | Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2026-07-21 | PHASE2 |
| NCT06168734 | WITHDRAWN | Ventilator-associated Pneumonia; Hospital-acquired Pneumonia |
Venatorx Pharmaceuticals, Inc. |
2025-06 | PHASE3 |
| NCT06633718 | NOT_YET_RECRUITING | Intra-abdominal Infections |
Qilu Pharmaceutical Co., Ltd. |
2024-10-31 | PHASE3 |
| 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 | |
| NCT03671967 | RECRUITING | Beta Lactam Resistant Bacterial Infection; Enterobacteriaceae Infections; Bacteremia |
Rambam Health Care Campus |
2019-05-01 | PHASE4 |
| NCT06672978 | ACTIVE_NOT_RECRUITING | Acute Pyelonephritis; Complicated Urinary Tract Infection |
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) |
2025-06-03 | PHASE2 |
| NCT06818565 | NOT_YET_RECRUITING | Acute-On-Chronic Liver Failure |
Institute of Liver and Biliary Sciences, India |
2025-02-10 | |
| NCT06342115 | RECRUITING | Febrile Neutropenia |
Beneficência Portuguesa de São Paulo |
2025-03-26 | PHASE4 |
| NCT07089186 | RECRUITING | Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP); Complicated Intra-abdominal Infection (cIAI); Complicated Urinary Tract Infection (cUTI); Bloodstream Infection (BSI) |
Qilu Pharmaceutical Co., Ltd. |
2025-04-12 | PHASE3 |
| NCT05578586 | RECRUITING | Drug Effect |
Oslo University Hospital |
2021-12-14 | |
| NCT07694700 | ACTIVE_NOT_RECRUITING | MDR Bacteria |
Beni-Suef University |
2025-12-30 | PHASE4 |
| NCT07524920 | NOT_YET_RECRUITING | MDR Bacteria |
Ain Shams University |
2026-04-01 | PHASE2 |
| NCT06426836 | RECRUITING | Pharmacokinetics; Amoxicillin-clavulanate; Piperacillin-tazobactam; Meropenem; Cefazolin; Teicoplanin; Vancomycin; Ciprofloxacin; Amikacin |
University Hospital, Ghent |
2016-08-19 | |
| NCT02687906 | COMPLETED | Bacterial Infections |
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) |
2016-07 | PHASE1 |
| NCT06828848 | RECRUITING | Gram Negative Infections |
Menarini Group |
2025-02-18 | PHASE2 |
| NCT05922124 | RECRUITING | Carbapenem Resistant Bacterial Infection; Acinetobacter Bacteremia; Acinetobacter Pneumonia |
Rambam Health Care Campus |
2024-09-01 | PHASE4 |
| NCT05565222 | UNKNOWN | Sepsis; Septic Shock |
Assistance Publique - Hôpitaux de Paris |
2023-03-11 | PHASE3 |
| NCT06198764 | UNKNOWN | Mental Health Issue |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2023-07-06 | PHASE3 |
| NCT06293677 | UNKNOWN | Febrile Neutropenia |
Centre Hospitalier Universitaire Vaudois |
2024-03-01 | PHASE4 |
| NCT06841731 | RECRUITING | Hospital-acquired Bacterial Pneumonia (HABP); Ventilator-associated Bacterial Pneumonia (VABP) |
Jiangsu HengRui Medicine Co., Ltd. |
2025-04-03 | PHASE2 |
| NCT07096310 | ACTIVE_NOT_RECRUITING | Sepsis |
Ain Shams University |
2024-01-01 | PHASE1; PHASE2 |
| NCT03630081 | UNKNOWN | Complicated Urinary Tract Infection; Acute Pyelonephritis |
Wockhardt |
2024-01 | PHASE3 |
| NCT07124468 | RECRUITING | Infections |
Qilu Pharmaceutical Co., Ltd. |
2025-09-13 | PHASE1 |
| NCT07445282 | COMPLETED | Extensively Drug-Resistant Typhoid Fever; Typhoid Fever; Salmonella Typhi Infection |
Sheikh Zayed Medical College |
2025-05-14 | PHASE4 |
| NCT06916156 | COMPLETED | Pharmacokinetics Study on Healthy Volunteers Adults |
Antabio |
2025-04-28 | PHASE1 |
| NCT05355350 | WITHDRAWN | Beta Lactam Resistant Bacterial Infection; Enterobacteriaceae Infections; Bacteremia |
Rambam Health Care Campus |
2022-07-01 | PHASE4 |
| NCT06527677 | COMPLETED | Renal Impairment |
Antabio |
2024-07-19 | PHASE1 |
| NCT05204368 | UNKNOWN | Complicated Urinary Tract Infection Including Acute Pyelonephritis |
Evopoint Biosciences Inc. |
2023-03-30 | PHASE3 |
| NCT06026852 | UNKNOWN | Infections |
University Hospital, Ghent |
2024-09-26 | |
| NCT05784844 | WITHDRAWN | Febrile Neutropenia |
Wake Forest University Health Sciences |
2024-08 | PHASE4 |
| NCT05393505 | UNKNOWN | Neutropenic Fever |
The University of Hong Kong |
2022-10-24 | PHASE4 |
| NCT04809259 | UNKNOWN | Infection, Bacterial |
University of Lausanne Hospitals |
2024-01-01 | EARLY_PHASE1 |
| NCT04478721 | COMPLETED | Bacteremia |
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
2020-12-15 | PHASE3 |
| NCT03891433 | SUSPENDED | Urinary Tract Infections; Enterobacteriaceae Infections; Infection Due to ESBL Bacteria; Carbapenem; Escherichia Coli Infection; Klebsiella Pneumoniae Infection; Clinical Trial; Drug Resistance, Bacterial |
Universidad del Norte |
2019-04-01 | PHASE4 |
| NCT04979806 | COMPLETED | Complicated Urinary Tract Infection; Acute Pyelonephritis |
Wockhardt |
2022-08-28 | PHASE3 |
| NCT07681544 | COMPLETED | Empirical Antimicrobial Therapy; Critically Ill; Meropenem; Pharmacokinetics and Pharmacodynamics |
Hospital Italiano de Buenos Aires |
2024-06-26 | |
| NCT06338345 | Not yet recruiting | Cardiogenic Shock|Post-cardiac Surgery|Cardiac Arrest|Extracorporeal Membrane Oxygenation Complication|Infections |
University Hospital Grenoble |
2024-09-01 | Not Applicable |
| NCT07122596 | COMPLETED | Sepsis; Bacterial Infection |
Pakistan Navy Station Shifa Hospital |
2024-04-01 | PHASE4 |
| NCT04238390 | WITHDRAWN | Bacteremia Caused by Gram-Negative Bacteria |
The University of Queensland |
2022-01 | PHASE3 |
| NCT05784844 | Recruiting | Febrile Neutropenia |
Wake Forest University Health Sciences |
2024-04 | Phase 4 |
| NCT05905913 | COMPLETED | Healthy Volunteers |
Antabio |
2023-04-12 | PHASE1 |
| NCT05427747 | UNKNOWN | Spontaneous Bacterial Peritonitis |
Assiut University |
2023-01-01 | PHASE4 |
| NCT04809259 | Not yet recruiting | Infection Bacterial |
University of Lausanne Hospitals |
2024-01-01 | Early Phase 1 |
| NCT06087536 | Not yet recruiting | Hospital-acquired Bacterial Pneumonia|Ventilator-associated Bacterial Pneumonia |
Omnix Medical Ltd |
2024-01 | Phase 2 |
| NCT05340530 | UNKNOWN | Infections |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2022-04 | PHASE1 |
| NCT06089668 | Recruiting | Melioidosis |
AN2 Therapeutics Inc|Mahidol Oxford Tropical Medicine Research Unit |
2023-11-01 | -- |
| NCT05105035 | COMPLETED | Melioidosis |
Arrevus Inc. |
2022-06-14 | PHASE2 |
| NCT04983901 | COMPLETED | Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm |
M.D. Anderson Cancer Center |
2021-09-14 | PHASE2 |
| NCT04816968 | UNKNOWN | Severe Bacterial Infections |
Ospedale San Carlo Borromeo |
2021-09 | PHASE1 |
| NCT05102162 | TERMINATED | Pneumonia |
University of Florida |
2021-12-17 | PHASE4 |
| NCT03329092 | COMPLETED | Complicated Intra-abdominal Infection; Hosptial Acquired Pneumonia; Ventilator Associated Pneumonia |
Pfizer |
2018-04-05 | PHASE3 |
| NCT05392634 | UNKNOWN | Bladder Cancer |
N.N. Petrov National Medical Research Center of Oncology |
2022-02-02 | PHASE3 |
| NCT04785924 | WITHDRAWN | Carbapenem-Resistant Enterobacteriaceae Infection; KPC; Gram-Negative Bacterial Infections; Antibiotic Resistant Infection |
Wake Forest University Health Sciences |
2021-06-07 | PHASE4 |
| NCT03452839 | COMPLETED | Antibiotic Resistant Infection; Critical Illness |
Università Vita-Salute San Raffaele |
2018-06-05 | PHASE4 |
| NCT05226923 | COMPLETED | Bacterial Infections |
Sumitovant Biopharma, Inc. |
2022-01-12 | PHASE1 |
| NCT07113574 | COMPLETED | Peritoneal Dialysis Associated Peritonitis; Peritoneal Dialysis (PD); Peritoneal Dialysis; Peritoneal Dialysis, Continuous Ambulatory; Meropenem; Aztreonam; Antibacterial Agents; Intraperitoneal Antibiotics; Kidney Failure, Chronic; Anti-Bacterial Agents; Drug Therapy |
Karl Landsteiner Insitute for Nephrology and Haemato-Oncology |
2021-08-31 | PHASE2; PHASE3 |
| NCT04671589 | UNKNOWN | Drug Toxicity |
Mabaret Al-Asafara Hospitals |
2021-06 | PHASE4 |
| NCT03174184 | COMPLETED | Tuberculosis, Pulmonary |
Johns Hopkins University |
2017-08-23 | PHASE2 |
| NCT05060419 | UNKNOWN | Complicated Urinary Tract Infection; Acute Pyelonephritis |
Qilu Pharmaceutical Co., Ltd. |
2021-10-08 | PHASE2 |
| NCT04876430 | TERMINATED | Carbapenem-Resistant Enterobacteriaceae Infection; Bloodstream Infection |
Hospital de Clinicas de Porto Alegre |
2021-05-04 | PHASE2; PHASE3 |
| NCT04555798 | COMPLETED | Patients With Respiratory Failure and Shocked |
Mohamed Gaber Allam |
2022-02-01 | PHASE1; PHASE2 |
| NCT04233996 | UNKNOWN | Febrile Neutropenia |
Hospital Universitari de Bellvitge |
2019-06-05 | PHASE4 |
| NCT03840148 | COMPLETED | Urinary Tract Infections; Acute Pyelonephritis |
Venatorx Pharmaceuticals, Inc. |
2019-08-07 | PHASE3 |
| NCT06739382 | COMPLETED | Ventilation Acquired Pneumonia |
Beni-Suef University |
2021-01-01 | PHASE3 |
| NCT06072222 | COMPLETED | ARDS; Septic Shock |
King Abdul Aziz Specialist Hospital |
2020-07-02 | PHASE1; PHASE2 |
| NCT04553367 | COMPLETED | ARDS; Septic Shock |
King Abdul Aziz Specialist Hospital |
2020-07-02 | PHASE1; PHASE2 |
| NCT06072248 | COMPLETED | ARDS; Septic Shock |
King Abdul Aziz Specialist Hospital |
2020-07-02 | PHASE1; PHASE2 |
| NCT04370145 | COMPLETED | Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific |
Tongji Hospital |
2021-05-01 | PHASE4 |
| NCT03717350 | UNKNOWN | Sepsis |
Hellenic Institute for the Study of Sepsis |
2018-10-27 | PHASE2; PHASE3 |
| NCT04629378 | COMPLETED | Tuberculosis |
TASK Applied Science |
2020-08-17 | PHASE2 |
| NCT03485950 | COMPLETED | Other Infectious Diseases |
M.D. Anderson Cancer Center |
2018-05-16 | PHASE2 |
| NCT05058105 | COMPLETED | Healthy |
Qilu Pharmaceutical Co., Ltd. |
2020-10-08 | PHASE1 |
| NCT05896930 | COMPLETED | Pulmonary Tuberculosis |
TASK Applied Science |
2017-11-09 | PHASE2 |
| NCT02437045 | COMPLETED | Bloodstream Infections |
The University of Queensland |
2015-04 | PHASE4 |
| NCT04154722 | COMPLETED | Typhoid Fever |
Ziauddin University |
2019-06-20 | PHASE4 |
| NCT03230838 | COMPLETED | Complicated Urinary Tract Infection; Pyelonephritis |
Merck Sharp & Dohme LLC |
2018-04-26 | PHASE2 |
| NCT03543436 | COMPLETED | Urinary Tract Infections |
Assistance Publique - Hôpitaux de Paris |
2019-01-04 | PHASE3 |
| NCT03830333 | COMPLETED | Complicated Intra-abdominal Infections |
Merck Sharp & Dohme LLC |
2019-03-20 | PHASE3 |
| NCT01597973 | COMPLETED | Pneumonia; Blood Stream Infection |
University of Michigan |
2012-10-06 | PHASE3 |
| NCT04489459 | UNKNOWN | Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae |
Al-Azhar University |
2019-09-21 | PHASE4 |
| NCT03006679 | WITHDRAWN | Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia; Hospital-Acquired Pneumonia; Ventilator-Associated Pneumonia |
Melinta Therapeutics, Inc. |
2018-08 | PHASE3 |
| NCT03217136 | COMPLETED | Complicated Intra-Abdominal Infection |
Merck Sharp & Dohme LLC |
2018-04-03 | PHASE2 |
| NCT02047773 | COMPLETED | Bronchiectasis |
University of Edinburgh |
2014-01 | PHASE4 |
| NCT03019965 | COMPLETED | Sepsis |
Coordinación de Investigación en Salud, Mexico |
2017-02-01 | |
| NCT03884881 | UNKNOWN | Pneumonia; Metagenomic Next Generation Sequencing |
Xiangya Hospital of Central South University |
2018-01-01 | |
| NCT03645668 | COMPLETED | Sepsis |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
2018-01-30 | PHASE4 |
| NCT02149329 | COMPLETED | Febrile Neutropenia; Hematological Malignancy |
Amsterdam UMC, location VUmc |
2014-12 | PHASE4 |
| NCT03915236 | TERMINATED | Lower Respiratory Tract Infection |
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
2019-02-18 | |
| NCT03032380 | COMPLETED | Healthcare-associated Pneumonia (HCAP); Hospital Acquired Pneumonia (HAP); Ventilator Associated Pneumonia (VAP) |
Shionogi |
2017-10-24 | PHASE3 |
| NCT02142751 | COMPLETED | Infection Due to ESBL Escherichia Coli |
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
2014-07 | PHASE3 |
| NCT03344627 | COMPLETED | Sepsis; Septic Shock; Critical Illness; Carbapenem; Pharmacokinetic; Pharmacodynamic; Clinical Outcome; Organ Failure, Multiple; Morality |
Mahidol University |
2017-11-27 | |
| NCT03564158 | COMPLETED | Healthy |
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) |
2018-05-01 | PHASE1 |
| NCT02820987 | COMPLETED | Septic Shock |
Centre Hospitalier Universitaire de Besancon |
2016-09-27 | PHASE3 |
| NCT03157388 | COMPLETED | Alcoholic Hepatitis |
University of Aarhus |
2017-06-01 | |
| NCT02070757 | COMPLETED | Healthcare-Associated Pneumonia; Ventilator-Associated Pneumonia; Lung Diseases |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2014-09-02 | PHASE3 |
| NCT03174795 | COMPLETED | Urinary Tract Infections |
Hoffmann-La Roche |
2017-07-11 | PHASE1 |
| NCT02840136 | TERMINATED | Cystic Fibrosis |
University Ghent |
2016-02 | |
| NCT03182504 | COMPLETED | Gram-negative Bacterial Infections |
Hoffmann-La Roche |
2017-06-15 | PHASE1 |
| NCT02168946 | COMPLETED | Urinary Tract Infection Complicated; Acute Pyelonephritis; Hospital Acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Bacteremia; Abdominal Infection |
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) |
2014-07 | PHASE3 |
| NCT02788240 | TERMINATED | Acute on Chronic Liver Failure |
Institute of Liver and Biliary Sciences, India |
2016-05-01 | |
| NCT02176122 | TERMINATED | Bloodstream Infections |
The University of Queensland |
2014-02 | PHASE4 |
| NCT07113587 | COMPLETED | Peritoneal Dialysis-associated Peritonitis; Peritoneal Dialysis (PD); Pharmacokinetics; Intravenous Administration; Intravenous; Meropenem; Intraperitoneal; Ampicillin; Aztreonam; Ciprofloxacin; Minimum Inhibitory Concentration (MIC) |
Karl Landsteiner Insitute for Nephrology and Haemato-Oncology |
2014-04-08 | PHASE2; PHASE3 |
| NCT01667094 | UNKNOWN | Cystic Fibrosis |
The Alfred |
2012-09 | PHASE4 |
| NCT02475733 | COMPLETED | Complicated Intra-abdominal Infections |
Pfizer |
2015-08-01 | PHASE2 |
| NCT01828892 | UNKNOWN | Low-output External Gastrointestinal Fistula |
Jinling Hospital, China |
2014-03 | |
| NCT02463747 | UNKNOWN | Fever; Febrile Neutropenia |
Tel-Aviv Sourasky Medical Center |
2015-06 | PHASE4 |
| NCT03477422 | COMPLETED | Urinary Tract Infection Complicated; Acute Pyelonephritis |
Venus Remedies Limited |
2014-01-11 | PHASE3 |
| NCT02784704 | COMPLETED | Complicated Intra-abdominal Infections; Complicated Appendicitis |
Tetraphase Pharmaceuticals, Inc |
2016-10-13 | PHASE3 |
| NCT02972255 | COMPLETED | Healthy Volunteers |
Hoffmann-La Roche |
2016-10-31 | PHASE1 |
| NCT01732250 | COMPLETED | Gram-Negative Bacterial Infections |
Mical Paul |
2013-03 | PHASE4 |
| NCT02486627 | COMPLETED | Complicated Urinary Tract Infection; Acute Pyelonephritis |
Achaogen, Inc. |
2016-01-11 | PHASE3 |
| NCT01970371 | COMPLETED | Bloodstream Infections (BSI) Due to CRE; Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE; Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE; Complicated Urinary Tract Infection (cUTI) Due to CRE; Acute Pyelonephritis (AP) Due to CRE |
Achaogen, Inc. |
2014-09-16 | PHASE3 |
| NCT02732327 | TERMINATED | Neoplasms; Febrile Neutropenia |
Forest Laboratories |
2016-05-17 | PHASE2 |
| NCT02166476 | COMPLETED | Urinary Tract Infection Complicated; Acute Pyelonephritis |
Melinta Therapeutics, Inc. |
2014-11-20 | PHASE3 |
| NCT01808092 | COMPLETED | Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP) |
Pfizer |
2013-04 | PHASE3 |
| NCT01292031 | COMPLETED | Ventilator-associated Bacterial Pneumonia |
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
2012-05 | PHASE3 |
| NCT01992198 | UNKNOWN | Pancreatitis,Acute Necrotizing |
Erzhen Chen |
2012-07 | PHASE4 |
| NCT01944319 | COMPLETED | Lower Respiratory Tract Infection |
Qingtao Zhou |
2013-07 | PHASE4 |
| NCT02503761 | COMPLETED | Late Onset Neonatal Sepsis |
Mansoura University |
2013-08 | PHASE3 |
| NCT01570192 | TERMINATED | Bacterial Pneumonia |
University of Florida |
2010-09 | PHASE2 |
| NCT01726023 | COMPLETED | Complicated Intra-abdominal Infection |
Pfizer |
2013-01 | PHASE3 |
| NCT02349841 | COMPLETED | Pulmonary Tuberculosis |
TASK Applied Science |
2014-09 | PHASE2 |
| NCT01551394 | COMPLETED | Sepsis |
PENTA Foundation |
2012-09 | PHASE3 |
| NCT01554124 | COMPLETED | Meningitis |
PENTA Foundation |
2013-02 | PHASE1; PHASE2 |
| NCT02344563 | COMPLETED | Healthy |
Yung Shin Pharm. Ind. Co., Ltd. |
2014-09 | PHASE4 |
| NCT01499290 | COMPLETED | Complicated Intra-Abdominal Infection |
Pfizer |
2012-03 | PHASE3 |
| NCT01455246 | TERMINATED | Cirrhosis; Ascites; Nosocomial Spontaneous Bacterial Peritonitis |
University of Padova |
2010-10 | PHASE2; PHASE3 |
| NCT01429259 | COMPLETED | Cystic Fibrosis; Pneumonia; Pseudomonas Aeruginosa Infection |
Joseph Kuti |
2012-02 | PHASE4 |
| NCT01158937 | TERMINATED | Cystic Fibrosis Pulmonary Exacerbation |
Unity Health Toronto |
2010-05 | |
| NCT02212392 | COMPLETED | Acute Pancreatitis |
Benazir Bhutto Hospital, Rawalpindi |
2013-01 | PHASE1; PHASE2 |
| NCT02213796 | COMPLETED | Initial Phase of Severe Sepsis and Septic Shock |
Sutep Jaruratanasirikul |
2013-01 | PHASE4 |
| NCT01445678 | COMPLETED | Complicated Intra-abdominal Infection |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2011-12-23 | PHASE3 |
| NCT01110382 | TERMINATED | Abscess, Intra-Abdominal; Abdominal Abscess; Abdomen, Acute; Abdominal Pain; Appendicitis; Rupture; Infection; Intestinal Perforation; Peritonitis; Ileus |
Janssen Research & Development, LLC |
2010-12 | PHASE3 |
| NCT01297842 | UNKNOWN | Drug Safety |
Mahidol University |
2011-05 | PHASE4 |
| NCT01633762 | COMPLETED | Diabetes; Obesity; Osteoporosis; Inflammation |
University Hospital, Gentofte, Copenhagen |
2012-04 | EARLY_PHASE1 |
| NCT01381562 | TERMINATED | Infections, Intestinal |
GlaxoSmithKline |
2011-10-03 | PHASE2 |
| NCT01147640 | COMPLETED | Complicated Intra-abdominal Infection |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2010-06-25 | PHASE2 |
| NCT01044719 | UNKNOWN | Cystic Fibrosis |
Imperial College London |
2010-01 | PHASE4 |
| NCT00579956 | UNKNOWN | Melioidosis |
University of Oxford |
2007-12 | |
| NCT00534287 | COMPLETED | Severe Sepsis; Septic Shock |
Kompetenznetz Sepsis |
2007-10 | PHASE3 |
| NCT00891423 | COMPLETED | Sepsis |
Austin Health |
2009-04 | |
| NCT02506686 | COMPLETED | Central Nervous System Infections |
Huashan Hospital |
2008-09 | PHASE4 |
| NCT00752219 | COMPLETED | Complicated Intra-abdominal Infections |
Pfizer |
2009-03-31 | PHASE2 |
| NCT00621192 | COMPLETED | Necrotizing Enterocolitis; Intra-abdominal Infection |
The Emmes Company, LLC |
2008-06 | PHASE1; PHASE2 |
| NCT00771316 | TERMINATED | Urinary Tract Infections |
Merck Sharp & Dohme LLC |
2008-12 | PHASE3 |
| NCT00307099 | TERMINATED | Bacterial Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-10 | PHASE3 |
| NCT00318552 | COMPLETED | Sepsis |
Pfizer |
2002-01 | PHASE4 |
| NCT00318994 | COMPLETED | Pancreatitis |
Pfizer |
2002-02 | PHASE4 |
| NCT02615041 | COMPLETED | Ventilator-Associated Pneumonia |
Sutep Jaruratanasirikul |
2004-01 | PHASE4 |
| NCT00061438 | COMPLETED | Pancreatitis, Acute Necrotizing |
Pfizer |
2003-02 | PHASE4 |
| NCT00619710 | COMPLETED | Skin Infection; Abscess; Cellulitis |
Pfizer |
2001-02 | PHASE3 |
| NCT00153634 | COMPLETED | Cystic Fibrosis; Chronic Bronchitis |
Seattle Children's Hospital |
2004-03 | |
| NCT00438269 | COMPLETED | Nosocomial Infection; Pneumonia; Systemic Inflammatory Response Syndrome; Critical Illness; Pyrexia |
Canadian Critical Care Trials Group |
2003-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-12)
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>).