Numerous clinical trials spanning Phase 1 through Phase 4 evaluate imipenem for bacterial infections, including complicated urinary tract infections, sepsis, bacterial pneumonia in cystic fibrosis, and carbapenem-resistant Enterobacteriaceae. These studies assess safety, pharmacokinetics, clinical efficacy, and combination regimens with relebactam and cilastatin in diverse populations, such as critically ill and obese patients. Sponsored by pharmaceutical companies, academic hospitals, and research foundations, their recruitment statuses range from completed and actively recruiting to withdrawn or enrolling by invitation.
| 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 |
| NCT04310930 | RECRUITING | Pulmonary Disease Due to Mycobacteria (Diagnosis) |
The University of Queensland |
2020-03-02 | PHASE2; PHASE3 |
| NCT07759453 | NOT_YET_RECRUITING | Liver Transplant; Carbapenem-resistant Enterobacterales; CRE Colonization |
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
2026-10-01 | PHASE3 |
| NCT05925309 | RECRUITING | Biliary Atresia; Cholangitis; Anti-Bacterial Agents |
Children's Hospital of Fudan University |
2023-07-01 | |
| NCT07228702 | ENROLLING_BY_INVITATION | Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection |
Vancouver Coastal Health |
2026-01-11 | PHASE1 |
| NCT07524920 | NOT_YET_RECRUITING | MDR Bacteria |
Ain Shams University |
2026-04-01 | PHASE2 |
| NCT06569056 | RECRUITING | Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP) |
Jiangsu HengRui Medicine Co., Ltd. |
2024-09-25 | PHASE3 |
| NCT05204368 | UNKNOWN | Complicated Urinary Tract Infection Including Acute Pyelonephritis |
Evopoint Biosciences Inc. |
2023-03-30 | PHASE3 |
| NCT06059846 | COMPLETED | Urinary Tract Infection; Acute Pyelonephritis |
Spero Therapeutics |
2023-12-21 | PHASE3 |
| NCT05887908 | COMPLETED | Complicated Urinary Tract Infection; Acute Pyelonephritis; cUTI; AP |
Meiji Seika Pharma Co., Ltd. |
2023-05-23 | PHASE3 |
| NCT05561764 | TERMINATED | Cystic Fibrosis; Pneumonia, Bacterial |
Hartford Hospital |
2023-01-03 | PHASE4 |
| NCT05204563 | COMPLETED | Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia |
Evopoint Biosciences Inc. |
2022-07-31 | PHASE3 |
| NCT03012360 | TERMINATED | Mechanical Ventilation Complication; Critical Illness |
University Hospital, Lille |
2018-02-08 | PHASE4 |
| NCT06144060 | UNKNOWN | Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP) |
Jiangsu HengRui Medicine Co., Ltd. |
2023-12 | PHASE2 |
| NCT04983901 | COMPLETED | Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm |
M.D. Anderson Cancer Center |
2021-09-14 | PHASE2 |
| NCT05146154 | WITHDRAWN | Obesity; Critical Illness |
University of Illinois at Chicago |
2023-01-01 | PHASE4 |
| NCT04493151 | COMPLETED | Sepsis |
Joseph L. Kuti, PharmD |
2021-01-01 | PHASE1 |
| NCT04785924 | WITHDRAWN | Carbapenem-Resistant Enterobacteriaceae Infection; KPC; Gram-Negative Bacterial Infections; Antibiotic Resistant Infection |
Wake Forest University Health Sciences |
2021-06-07 | PHASE4 |
| NCT05561764 | Recruiting | Cystic Fibrosis|Pneumonia Bacterial |
Hartford Hospital|Merck Sharp & Dohme LLC|Q2 Solutions|Connecticut Children''s Medical Center|St. Christopher''s Hospital for Children|University of Texas Southwestern Medical Center|University of Pittsburgh Medical Center|Indiana University Health Methodist Hospital|James Whitcomb Riley Hospital for Children |
2023-01-03 | Phase 4 |
| NCT05146154 | Enrolling by invitation | Obesity|Critical Illness |
University of Illinois at Chicago|Merck Sharp & Dohme LLC |
2023-01-01 | Phase 4 |
| NCT05516433 | Recruiting | Enterobacteriaceae Infections |
Fondation Hôpital Saint-Joseph |
2023-01-23 | -- |
| NCT03583333 | COMPLETED | Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia |
Merck Sharp & Dohme LLC |
2018-09-18 | PHASE3 |
| NCT05285046 | Unknown status | Bacterial Infections|Antibiotic Resistant Infection |
D''Or Institute for Research and Education |
2022-04-01 | -- |
| NCT04208763 | UNKNOWN | Spontaneous Bacterial Peritonitis |
Institute of Liver and Biliary Sciences, India |
2019-12-20 | |
| NCT04801043 | COMPLETED | Bacterial Infections |
Evopoint Biosciences Inc. |
2021-03-02 | PHASE1 |
| NCT04787562 | COMPLETED | Bacterial Infections |
Evopoint Biosciences Inc. |
2021-02-25 | PHASE1 |
| NCT04147221 | COMPLETED | Sepsis |
Hartford Hospital |
2020-02-10 | PHASE1 |
| NCT03177720 | COMPLETED | Pneumonia |
Medical University of Vienna |
2016-05-29 | PHASE1 |
| NCT03894046 | COMPLETED | Acinetobacter Baumannii-calcoaceticus Complex; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Bacteremia; Colistin Resistant ABC |
Entasis Therapeutics |
2019-09-05 | PHASE3 |
| NCT04802863 | COMPLETED | Bacterial Infections |
Evopoint Biosciences Inc. |
2021-03-25 | PHASE1 |
| NCT04802863 | Completed | Bacterial Infections |
Evopoint Biosciences Inc. |
2021-03-25 | Phase 1 |
| NCT04801043 | Completed | Bacterial Infections |
Evopoint Biosciences Inc. |
2021-03-02 | Phase 1 |
| NCT04482569 | COMPLETED | Bacterial Infections |
Evopoint Biosciences Inc. |
2020-07-10 | PHASE1 |
| NCT03543436 | COMPLETED | Urinary Tract Infections |
Assistance Publique - Hôpitaux de Paris |
2019-01-04 | PHASE3 |
| NCT03008746 | COMPLETED | Chronic Obstructive Pulmonary Disease |
CHU de Reims |
2017-01-12 | |
| 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 | |
| NCT03733340 | UNKNOWN | Antibacterial Prophylaxis; Hematological Malignancies; Allogenetic Hematopoietic Stem Cell Transplantation; Imipenem |
Nanfang Hospital, Southern Medical University |
2018-12-01 | PHASE2; PHASE3 |
| NCT02149329 | COMPLETED | Febrile Neutropenia; Hematological Malignancy |
Amsterdam UMC, location VUmc |
2014-12 | PHASE4 |
| NCT02493764 | COMPLETED | Bacterial Pneumonia |
Merck Sharp & Dohme LLC |
2015-11-24 | PHASE3 |
| NCT03293485 | COMPLETED | Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection |
Merck Sharp & Dohme LLC |
2017-10-04 | PHASE3 |
| NCT03445195 | COMPLETED | Complicated Urinary Tract Infection; Acute Pyelonephritis |
Entasis Therapeutics |
2018-01-17 | PHASE2 |
| NCT03776305 | UNKNOWN | Critically Ill Patients With ECMO |
Prince of Songkla University |
2015-12-01 | PHASE4 |
| NCT02474706 | TERMINATED | Urinary Tract Infections |
Central Hospital, Nancy, France |
2016-03 | PHASE4 |
| NCT02452047 | COMPLETED | Bacterial Infections |
Merck Sharp & Dohme LLC |
2015-08-21 | PHASE3 |
| NCT02971423 | COMPLETED | Acinetobacter Baumannii Infection |
Entasis Therapeutics |
2016-10 | PHASE1 |
| NCT02897206 | COMPLETED | Acute Pancreatitis |
University Hospital Rijeka |
2014-10 | PHASE4 |
| NCT02321800 | COMPLETED | Urinary Tract Infections |
Shionogi |
2015-02-05 | PHASE2 |
| NCT01852630 | COMPLETED | Spontaneous Bacterial Peritonitis |
Institute of Liver and Biliary Sciences, India |
2012-12 | |
| NCT02616354 | UNKNOWN | Sepsis |
Southeast University, China |
2015-01 | PHASE4 |
| NCT01721408 | COMPLETED | Intra-abdominal Infection |
Pfizer |
2012-11 | PHASE4 |
| NCT01659866 | COMPLETED | Infection |
Northwestern University |
2012-08 | PHASE4 |
| NCT01505634 | COMPLETED | Urinary Tract Infections; Pyelonephritis |
Merck Sharp & Dohme LLC |
2012-05-16 | PHASE2 |
| NCT01820026 | UNKNOWN | Cirrhosis |
University of Roma La Sapienza |
2012-12 | PHASE4 |
| NCT02683603 | COMPLETED | Pneumonia, Ventilator-Associated |
Tunis University |
2013-04 | PHASE4 |
| NCT01506271 | COMPLETED | Intra-abdominal Infections |
Merck Sharp & Dohme LLC |
2012-06-01 | PHASE2 |
| NCT00871104 | COMPLETED | Infective Endocarditis |
Juan A. Arnaiz |
2009-07 | PHASE4 |
| NCT01714570 | COMPLETED | Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation |
Chinese PLA General Hospital |
2012-11 | |
| NCT01379157 | COMPLETED | Ventilator Associated Pneumonia |
Prince of Songkla University |
2011-11 | PHASE4 |
| NCT02213783 | COMPLETED | Patients With Febrile Neutropenia |
Prince of Songkla University |
2011-02 | PHASE4 |
| NCT01356472 | UNKNOWN | Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated |
Ruijin Hospital |
2011-06 | PHASE4 |
| NCT01297842 | UNKNOWN | Drug Safety |
Mahidol University |
2011-05 | PHASE4 |
| NCT01381549 | TERMINATED | Infections, Urinary Tract |
GlaxoSmithKline |
2011-06-28 | PHASE2 |
| NCT01275170 | COMPLETED | Infectious Disease |
Merck Sharp & Dohme LLC |
2011-01-28 | PHASE1 |
| NCT00950222 | COMPLETED | Ventilator Associated Pneumonia |
Assistance Publique - Hôpitaux de Paris |
2009-06 | |
| NCT00589693 | TERMINATED | Ventilator-Associated Pneumonia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2008-04 | PHASE3 |
| NCT00707239 | TERMINATED | Pneumonia, Bacterial |
Pfizer |
2008-12 | PHASE2 |
| NCT00690378 | COMPLETED | Complicated Urinary Tract Infection |
Pfizer |
2008-11 | PHASE2 |
| NCT01489124 | COMPLETED | Ventilator-Associated Pneumonia |
Sutep Jaruratanasirikul |
2008-01 | PHASE4 |
| NCT00515034 | COMPLETED | Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia; Abdominal Abscess; Bacterial Infections |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-10 | PHASE2 |
| NCT00445094 | COMPLETED | Infection; Pneumonia |
Merck Sharp & Dohme LLC |
2006-11 | PHASE4 |
| NCT00136201 | COMPLETED | Abdominal Abscess |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-11 | PHASE3 |
| NCT00081744 | COMPLETED | Gram-Positive Bacterial Infections; Cross Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2002-11 | PHASE3 |
| NCT00619710 | COMPLETED | Skin Infection; Abscess; Cellulitis |
Pfizer |
2001-02 | PHASE3 |
| NCT00080496 | COMPLETED | Bacterial Pneumonia |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-07 | PHASE3 |
| NCT00236834 | COMPLETED | Nosocomial Pneumonia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
1997-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-03-20)
Check the
Imipenem
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.