Clinical Trials

Ertapenem sodium has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its safety, efficacy, and pharmacokinetics for bacterial infections, including pneumonia, complicated urinary tract infections, surgical site infections, skin and soft tissue infections, and diabetic foot infections. Sponsored by pharmaceutical developers like Merck Sharp & Dohme LLC as well as major academic institutions, these studies assess therapeutic outcomes and resource utilization across patient populations. Overall trial statuses range from completed and actively recruiting to suspended or terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04140578 RECRUITING
Gastric Varix; Sepsis; Liver Cirrhoses; Fever
Taipei Veterans General Hospital, Taiwan
 2017-01-28 PHASE4
NCT05224401 RECRUITING
Urinary Tract Infections; Bacteremia; Antibiotic Resistant Infection
Lund University
 2023-05-29 PHASE3
NCT04886284 RECRUITING
Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Septicemia; Staphylococcal Sepsis; Staphylococcus Aureus Endocarditis
Todd C. Lee MD MPH FIDSA
 2024-05-20 PHASE2
NCT06920147 NOT_YET_RECRUITING
Surgical Site Infection
The University of Texas Health Science Center, Houston
 2025-05-01 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
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
NCT02729116 UNKNOWN
Anti-Infective Agents, Urinary; Escherichia Coli Infections; Klebsiella Infections; Kidney Transplantation; Urinary Tract Infections
Khon Kaen University
 2016-07 PHASE2; PHASE3
NCT05645757 COMPLETED
Bacterial Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2023-04-19 PHASE1
NCT03257423 UNKNOWN
Acute Appendicitis
Turku University Hospital
 2017-04-04
NCT06739382 COMPLETED
Ventilation Acquired Pneumonia
Beni-Suef University
 2021-01-01 PHASE3
NCT03218800 TERMINATED
Urinary Tract Infections
Instituto Nacional de Cancer, Brazil
 2017-06-01 PHASE3
NCT05896930 COMPLETED
Pulmonary Tuberculosis
TASK Applied Science
 2017-11-09 PHASE2
NCT03234296 ENROLLING_BY_INVITATION
Acute Appendicitis
Turku University Hospital
 2017-08-09
NCT03294395 COMPLETED
Gonorrhea
Public Health Service of Amsterdam
 2017-09-18 PHASE3
NCT03788967 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis
Spero Therapeutics
 2019-06-03 PHASE3
NCT04505683 COMPLETED
Complicated Urinary Tract Infection Including Acute Pyelonephritis
Sihuan Pharmaceutical Holdings Group Ltd.
 2018-12-13 PHASE2; PHASE3
NCT02800785 COMPLETED
Appendicitis
University of Washington
 2016-05
NCT03357614 COMPLETED
Complicated Urinary Tract Infections
Iterum Therapeutics, International Limited
 2018-09-18 PHASE3
NCT03358576 COMPLETED
Intra Abdominal Infections
Iterum Therapeutics, International Limited
 2018-09-18 PHASE3
NCT03582007 TERMINATED
Pneumonia
Polyphor Ltd.
 2018-10-22 PHASE3
NCT03859362 UNKNOWN
Patients With Urosepis and Received Ertapenem for Treatment
Prince of Songkla University
 2017-01 PHASE4
NCT03236961 ACTIVE_NOT_RECRUITING
Acute Appendicitis
Turku University Hospital
 2017-04-03
NCT02789865 UNKNOWN
Acute Appendicitis
First Affiliated Hospital Xi'an Jiaotong University
 2016-05 PHASE2
NCT01723150 COMPLETED
Liver Abscess, Pyogenic
National University Hospital, Singapore
 2013-11-05 PHASE4
NCT03032510 COMPLETED
Complicated Urinary Tract Infections
Tetraphase Pharmaceuticals, Inc
 2017-01 PHASE3
NCT01730664 COMPLETED
PK of Ertapenem in TB Patients
University Medical Center Groningen
 2017-01-26 PHASE2
NCT02505386 COMPLETED
Infections
University Hospital, Bordeaux
 2014-08 PHASE4
NCT02159859 COMPLETED
End Stage Renal Disease
Corewell Health East
 2014-12 PHASE2
NCT01937832 UNKNOWN
Community Acquired Pneumonia
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2013-10 PHASE3
NCT02447224 COMPLETED
Acute Uncomplicated Appendicitis
Olive View-UCLA Education & Research Institute
 2015-03 EARLY_PHASE1
NCT02537847 UNKNOWN
Infection Due to Escherichia Coli; Acute Pyelonephritis
Mahidol University
 2012-11 PHASE2
NCT01069900 COMPLETED
Intraabdominal Infections
Bayer
 2010-07-21 PHASE3
NCT02041767 COMPLETED
Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection
Assistance Publique - Hôpitaux de Paris
 2013-12 PHASE4
NCT01421901 UNKNOWN
Acute Appendicitis Without Peritonitis
A.O. Ospedale Papa Giovanni XXIII
 2011-08 PHASE4
NCT01844856 COMPLETED
Complicated Intra-abdominal Infections
Tetraphase Pharmaceuticals, Inc
 2013-08 PHASE3
NCT01587495 TERMINATED
Endometritis
Daniel Benjamin
 2012-03 PHASE1
NCT01370616 COMPLETED
Infection; Diabetic Foot
Merck Sharp & Dohme LLC
 2011-09-02 PHASE3
NCT02724410 COMPLETED
Perforated Appendicitis
Wake Forest University Health Sciences
 2011-01
NCT01297842 UNKNOWN
Drug Safety
Mahidol University
 2011-05 PHASE4
NCT01886053 COMPLETED
Community Acquired Pneumonia
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2011-04 PHASE2
NCT01022567 UNKNOWN
Acute Appendicitis
Turku University Hospital
 2009-11
NCT01265784 COMPLETED
Complicated Intra-abdominal Infection
Tetraphase Pharmaceuticals, Inc
 2011-01 PHASE2
NCT01254344 COMPLETED
Infection; Surgical Site Infection
Merck Sharp & Dohme LLC
 2010-12 PHASE3
NCT01497990 COMPLETED
Burn Patients
Nantes University Hospital
 2010-01 PHASE4
NCT01159379 UNKNOWN
IgE-Mediated Hypersensitivity; Allergy
Catholic University of the Sacred Heart
 2011-01 PHASE4
NCT00877370 COMPLETED
Acute Kidney Failure
University of Michigan
 2009-02 PHASE4
NCT00658866 COMPLETED
Soft Tissue Infection
Medical University of Vienna
 2008-02 PHASE4
NCT01203046 COMPLETED
SURGICAL SITE INFECTION
Silvia M. Pinango L.
 2010-12 PHASE2; PHASE3
NCT01148771 COMPLETED
Healthy
Hartford Hospital
 2010-08 PHASE4
NCT00630513 COMPLETED
Intra-Abdominal Infection
University of Bologna
 2008-01 PHASE4
NCT00939952 COMPLETED
Continuous Ambulatory Peritoneal Dialysis; End Stage Renal Disease
Albany College of Pharmacy and Health Sciences
 2009-06 PHASE4
NCT00535652 COMPLETED
Diverticulosis, Colonic; Rectal Neoplasms; Colonic Neoplasms
University of Ulm
 2007-09 PHASE4
NCT00771316 TERMINATED
Urinary Tract Infections
Merck Sharp & Dohme LLC
 2008-12 PHASE3
NCT00489138 TERMINATED
To Assess the Tissular and Plasma Kinetics of Ertapenem
Assistance Publique Hopitaux De Marseille
 2007-04 PHASE4
NCT00366249 COMPLETED
Bacterial Infections; Diabetic Foot; Osteomyelitis
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-01 PHASE3
NCT01014013 COMPLETED
Urinary Tract Infection
Merck Sharp & Dohme LLC
 2008-04 PHASE3
NCT00492726 COMPLETED
Infection
Bayer
 2006-07 PHASE3
NCT00379951 COMPLETED
Urinary Tract Infection
Merck Sharp & Dohme LLC
 2005-06 PHASE3
NCT00398099 COMPLETED
Infection; Pneumonia; Urinary Tract Infection
Merck Sharp & Dohme LLC
 2005-07 PHASE3
NCT00397956 COMPLETED
Sepsis
Merck Sharp & Dohme LLC
 2004-09 PHASE3
NCT00090272 COMPLETED
Colorectal Surgery
Merck Sharp & Dohme LLC
 2002-04 PHASE3
NCT00157898 COMPLETED
Complicated Intra-abdominal Infection
Merck Sharp & Dohme LLC
 2004-01 PHASE4
NCT00389987 COMPLETED
Complicated Intra-Abdominal Infections
Merck Sharp & Dohme LLC
 2001-09 PHASE3
NCT00229112 COMPLETED
Foot Infections in Diabetic Patients
Merck Sharp & Dohme LLC
 2001-04 PHASE3
NCT00092170 COMPLETED
Infections; Pelvic Infections
Merck Sharp & Dohme LLC
 2002-03 PHASE2
NCT00451386 COMPLETED
Urinary Tract Infections; Bacterial Pneumonia; Soft Tissue Infections
Merck Sharp & Dohme LLC
 2002-01 PHASE2
NCT00481702 COMPLETED
Intra-abdominal Infection
Merck Sharp & Dohme LLC
 2001-12 PHASE3
NCT01061047 COMPLETED
Healthy
Poitiers University Hospital
 PHASE1
NCT00097734 UNKNOWN
Diverticulitis, Colonic; Acute Disease
Klinikum Hanover-Siloah Hospital
 2004-07 PHASE4
NCT01073059 COMPLETED
Healthy
Chonbuk National University
 2009-08 PHASE1
NCT00392028 WITHDRAWN
Amputation
HaEmek Medical Center, Israel
 2006-11

(data from https://clinicaltrials.gov, updated on 2019-10-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ertapenem sodium binds to and inhibits essential penicillin-binding proteins involved in bacterial cell wall synthesis, thereby disrupting peptidoglycan cross-linking and weakening structural integrity. This enzymatic inhibition triggers osmotic lysis and rapid bacterial death, providing therapeutic efficacy against diverse bacterial pathogens implicated in clinical conditions such as pneumonia, surgical site infections, and complicated urinary tract 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>).

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Note: Technical data last updated: Sep 1, 2026.