Clinical Trials

Numerous clinical trials have evaluated ampicillin across diverse medical conditions, including bacterial skin diseases, perforated appendicitis, endocarditis, and DYT-1 dystonia. Spanning Phase 1 safety studies through Phase 4 post-marketing trials and observational protocols, these investigations reflect statuses ranging from completed and currently recruiting to withdrawn and terminated. Research sponsors include academic and clinical institutions—such as Uppsala University, Drexel University, and Children's Mercy Hospital—alongside commercial pharmaceutical entities like Pfizer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07183462 RECRUITING
Pregnancy Complications, Infectious; Premature Birth; Neonatal Diseases and Abnormalities; Antibiotic Prophylaxis; Latency Period; Prematurity
Sheba Medical Center
 2025-09-10 PHASE4
NCT05977400 NOT_YET_RECRUITING
Premature Birth; Antibiotics; Neurodevelopment
Sharp HealthCare
 2024-04 PHASE3
NCT06406114 RECRUITING
Drug Allergy; Cephalosporin Allergy; Drug Hypersensitivity; Antibiotic Allergy; Beta Lactam Adverse Reaction; Drug-Induced Anaphylaxis; Cephalosporin Reaction
Massachusetts General Hospital
 2025-05-05 PHASE2
NCT06494072 RECRUITING
Community Acquired Pneumonia in Children
Medical College of Wisconsin
 2024-08-22 PHASE4
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
NCT06423898 RECRUITING
Endocarditis, Infective
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2024-10-09 PHASE4
NCT07610486 RECRUITING
Early Onset Sepsis; Preterm Neonates; NICU; Ampicillin; Safety and Pharmacokinetics
Duke University
 2026-07-28 PHASE1; PHASE2
NCT07563504 NOT_YET_RECRUITING
Rupture of Membranes Prior to Onset of Labor
Sarawak General Hospital
 2026-07-01 PHASE4
NCT06336213 RECRUITING
Aortic Aneurysm and Dissection; Cardiac Valve Disease; Thoracic Aortic Aneurysm; Thoracic Aortic Dissection
Petrovsky National Research Centre of Surgery
 2024-01-23
NCT06440304 RECRUITING
Infections, Bacterial; Sepsis Bacterial
Clinical Hospital Centre Zagreb
 2025-01-30 PHASE4
NCT06396078 RECRUITING
Preterm Premature Rupture of Membrane; Pregnancy, High Risk; Preterm Birth
Ohio State University
 2024-07-18 PHASE4
NCT05922124 RECRUITING
Carbapenem Resistant Bacterial Infection; Acinetobacter Bacteremia; Acinetobacter Pneumonia
Rambam Health Care Campus
 2024-09-01 PHASE4
NCT03997266 COMPLETED
Microbial Colonization; Extreme Prematurity; Early-Onset Neonatal Sepsis; Late-Onset Neonatal Sepsis; Necrotizing Enterocolitis of Newborn; Death; Neonatal
Michael Morowitz
 2020-08-05 PHASE4
NCT07118384 RECRUITING
Acinetobacter Baumannii Infection
Cairo University
 2025-05-01
NCT05469984 RECRUITING
Preterm Labor With Preterm Delivery; Premature Rupture of Membranes Prolonged
Western Galilee Hospital-Nahariya
 2022-11-25
NCT06368102 COMPLETED
Surgical Site Infection
Uji Takeda Hospital
 2024-05-02 PHASE4
NCT07148622 COMPLETED
Preterm Premature Rupture of Membranes (PPROM); Prophylaxis; Perinatal Outcomes
Yuzuncu Yil University
 2024-10-01
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
NCT06448624 COMPLETED
Heart Block; CIED Related Infection; CIED-related Infections; Antibiotic Prophylaxis; Biomarkers
Universitas Diponegoro
 2024-04-01 PHASE4
NCT02829060 COMPLETED
Nephrolithiasis; Urinary Tract Infection (UTI); Sepsis
University of California, San Diego
 2016-01
NCT05156437 TERMINATED
Endocarditis
West Virginia University
 2022-03-16 PHASE4
NCT05051163 UNKNOWN
HIV-1-infection; Malnutrition, Child
Makerere University
 2021-06-14 PHASE2; PHASE3
NCT04041791 COMPLETED
Pneumonia
University of Oxford
 2019-08-19 PHASE3
NCT03060473 TERMINATED
Preterm Premature Rupture of Membranes (PPROM)
The University of Texas Medical Branch, Galveston
 2017-02-23 PHASE3
NCT06048692 UNKNOWN
Cesarean Section; Infection
Beni-Suef University
 2023-01-01 PHASE3
NCT03795194 TERMINATED
Complicated Appendicitis; Perforated Appendicitis
Phoenix Children's Hospital
 2019-05-01 PHASE4
NCT04647331 Recruiting
Infective Endocarditis
Uppsala University
 2021-06-01 --
NCT04202380 COMPLETED
Preterm Pre-labor Rupture of Membranes
Assiut University
 2020-01-01
NCT04290104 UNKNOWN
Cholecystitis; Acute, With Cholelithiasis
Konya Meram State Hospital
 2020-10-15 PHASE4
NCT02865564 COMPLETED
Gastrointestinal Diseases; Colic
University Medical Centre Ljubljana
 2016-11
NCT03560232 TERMINATED
Open Fracture; Post-Op Wound Infection
Mercy Health Ohio
 2018-07-09 PHASE4
NCT03369093 COMPLETED
Treatment Failure; Lethargy; Altered Mental Status; Convulsion, Non-Epileptic; Hypoxia; Feeding; Difficult, Newborn
International Centre for Diarrhoeal Disease Research, Bangladesh
 2018-01-01
NCT02477423 COMPLETED
Premature Birth of Newborn; Enterocolitis, Necrotizing
University of Chicago
 2015-07
NCT02579161 COMPLETED
Kidney Stones
Northwell Health
 2014-09 PHASE3
NCT02424734 TERMINATED
Late-onset Sepsis
Pfizer
 2015-08-04 PHASE2
NCT02819570 UNKNOWN
Premature Rupture of Membrane
Western Galilee Hospital-Nahariya
 2015-11 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
NCT01433757 COMPLETED
DYT-1; Dystonia
University of Florida
 2011-09 PHASE1
NCT02384200 COMPLETED
Nephrolithiasis; Urinary Tract Infections
University of California, San Diego
 2015-03 PHASE4
NCT01994993 COMPLETED
Complicated Intra Abdominal Infections
Michael Cohen-Wolkowiez
 2013-12 PHASE2; PHASE3
NCT01945450 UNKNOWN
Endometritis
Hadassah Medical Organization
 2014-01
NCT01888822 TERMINATED
Cholelithiasis
University of Roma La Sapienza
 2013-06 PHASE4
NCT02007603 COMPLETED
Infection During Hemodialysis
Medical University of Vienna
 2013-08 PHASE3
NCT01551394 COMPLETED
Sepsis
PENTA Foundation
 2012-09 PHASE3
NCT01312792 COMPLETED
Pneumonia
International Centre for Diarrhoeal Disease Research, Bangladesh
 2010-08
NCT03129620 Completed
Hypothermia
Drexel University
 2013-03 --
NCT00879190 COMPLETED
Chorioamnionitis
Stanford University
 2009-05 PHASE2; PHASE3
NCT00814905 WITHDRAWN
Chorioamnionitis
United States Naval Medical Center, Portsmouth
 2008-11-18
NCT01433757 Completed
DYT-1|Dystonia
University of Florida|Tyler''s Hope for a Dystonia Cure Inc
 2011-09 Phase 1
NCT01189487 COMPLETED
Pneumonia, Bacterial
Pfizer
 2010-10 PHASE3
NCT01118403 Withdrawn
Ventilator Associated Pneumonia
Hospital Pablo Tobón Uribe
 2011-03 Phase 4
NCT01633294 COMPLETED
Chorioamnionitis; Puerperal Endometritis; Neonatal Early Onset Sepsis; Neonatal Meningitis; Neonatal Pneumonia
Hospital de Santa Maria, Portugal
 2008-10 PHASE2; PHASE3
NCT00887276 TERMINATED
Community Acquired Pneumonia
University of Ulm
 2008-11 PHASE4
NCT00952796 COMPLETED
Intra-abdominal Infection
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2009-01 PHASE4
NCT00630513 COMPLETED
Intra-Abdominal Infection
University of Bologna
 2008-01 PHASE4
NCT00356148 COMPLETED
Breast Cancer
Marmara University
 2003-10 PHASE4
NCT01678365 COMPLETED
Complicated Appendicitis
HaEmek Medical Center, Israel
 2008-07 PHASE4
NCT01138852 COMPLETED
Surgical Site Infections
Attikon Hospital
 2004-07 PHASE4
NCT00462020 COMPLETED
Perforated Appendicitis
Children's Mercy Hospital Kansas City
 2007-03
NCT00368537 COMPLETED
Skin Diseases, Bacterial
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-09 PHASE4
NCT00044746 COMPLETED
Diabetes Mellitus; Diabetic Foot
Wyeth is now a wholly owned subsidiary of Pfizer
 2000-10 PHASE4
NCT01045902 COMPLETED
Pneumonia, Aspiration; Lung Abscess
Bayer
 2001-02 PHASE3
NCT00021671 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00137007 COMPLETED
Pneumonia
Pfizer
 2003-11 PHASE4
NCT00002052 COMPLETED
HIV Infections; Salmonella Infections
University of Southern California

(data from https://clinicaltrials.gov, updated on 2025-12-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ampicillin is a beta-lactam antibiotic that selectively binds to and inhibits penicillin-binding proteins, thereby blocking the transpeptidation step of peptidoglycan synthesis in the bacterial cell wall. This structural disruption induces osmotic instability and cell lysis, providing the bactericidal mechanism required to clear bacterial pathogens in clinical trial conditions such as endocarditis, pneumonia, and skin diseases.

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.