Clinical Trials

Numerous clinical trials evaluate piperacillin across Phase 1 through Phase 4, alongside observational and pharmacokinetic studies, targeting conditions such as severe pneumonia, sepsis, septic shock, acute respiratory distress syndrome, and appendicitis. Sponsored by academic medical centers, university hospitals, and pharmaceutical entities, trial statuses range from completed Phase 3 and Phase 4 evaluations to actively recruiting studies investigating empirical sepsis management.

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
NCT06954129 RECRUITING
Acute Kidney Injury
University of Pennsylvania
2026-01-28 PHASE4
NCT07620223 RECRUITING
Hepatobiliary Surgery; Prophylactic Antibiotics
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2026-05-24
NCT06123169 NOT_YET_RECRUITING
Pancreaticoduodenectomy; Antibiotherapy
University Hospital, Rouen
2026-07 PHASE3
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
NCT06712641 RECRUITING
Sepsis
University Hospital, Akershus
2026-04-23 PHASE4
NCT07484633 NOT_YET_RECRUITING
Infection; Sepsis; NICU; PICU; Beta Lactams
Semmelweis University
2026-04 PHASE4
NCT07481539 RECRUITING
Bacteria Infection; Piperacillin, Tazobactam Drug Combination
Azienda Sanitaria Universitaria Friuli Centrale
2026-03-24 PHASE2
NCT03078010 ACTIVE_NOT_RECRUITING
Intestinal Microbiome; Febrile Neutropenia
Memorial Sloan Kettering Cancer Center
2017-02-10 PHASE2
NCT03671967 RECRUITING
Beta Lactam Resistant Bacterial Infection; Enterobacteriaceae Infections; Bacteremia
Rambam Health Care Campus
2019-05-01 PHASE4
NCT06977347 NOT_YET_RECRUITING
Severe Community-acquired Pneumonia (sCAP)
CHOSEOK YOON
2025-06-15
NCT07352605 NOT_YET_RECRUITING
Diverticular Disease of Colon
Azienda Sanitaria di Firenze
2026-04
NCT06972537 RECRUITING
Pneumonia
Shandong University
2024-07-24
NCT06426836 RECRUITING
Pharmacokinetics; Amoxicillin-clavulanate; Piperacillin-tazobactam; Meropenem; Cefazolin; Teicoplanin; Vancomycin; Ciprofloxacin; Amikacin
University Hospital, Ghent
2016-08-19
NCT05565222 UNKNOWN
Sepsis; Septic Shock
Assistance Publique - Hôpitaux de Paris
2023-03-11 PHASE3
NCT06293677 UNKNOWN
Febrile Neutropenia
Centre Hospitalier Universitaire Vaudois
2024-03-01 PHASE4
NCT02735707 RECRUITING
Community-acquired Pneumonia, Influenza, COVID-19
UMC Utrecht
2016-04-11 PHASE3
NCT04948463 COMPLETED
Febrile Neutropenia
Murdoch Childrens Research Institute
2021-11-15 PHASE4
NCT06690905 COMPLETED
Infections; Obesity and Obesity-related Medical Conditions
CR-CSSS Champlain-Charles-Le Moyne
2025-02-26 PHASE4
NCT06422533 UNKNOWN
Hematologic Neoplasms; Neutropenia
Instituto Nacional de Cancerologia de Mexico
2023-11-07
NCT05355350 WITHDRAWN
Beta Lactam Resistant Bacterial Infection; Enterobacteriaceae Infections; Bacteremia
Rambam Health Care Campus
2022-07-01 PHASE4
NCT05943223 COMPLETED
Appendicitis Perforated
McMaster Children's Hospital
2024-09-09 PHASE2
NCT06026852 UNKNOWN
Infections
University Hospital, Ghent
2024-09-26
NCT03269994 COMPLETED
Pancreatic Cancer; Pancreas Cancer; Pancreatic Diseases
Memorial Sloan Kettering Cancer Center
2017-11-21 PHASE3
NCT05981079 UNKNOWN
Late-Onset Neonatal Sepsis
Shandong University
2023-07-31 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
NCT06338345 Not yet recruiting
Cardiogenic Shock|Post-cardiac Surgery|Cardiac Arrest|Extracorporeal Membrane Oxygenation Complication|Infections
University Hospital Grenoble
2024-09-01 Not Applicable
NCT04276480 COMPLETED
Enterobacteriaceae Infections
University Hospital, Bordeaux
2022-02-16
NCT05753735 TERMINATED
Pancreatic Fistula
Case Comprehensive Cancer Center
2024-01-18 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
NCT05608564 COMPLETED
Periodontitis
University of Belgrade
2023-01-17
NCT03262142 TERMINATED
COPD; Respiratory Tract Infections; Pseudomonas Aeruginosa; Bronchiectasis; Asthma
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
2018-01-10 PHASE4
NCT05102162 TERMINATED
Pneumonia
University of Florida
2021-12-17 PHASE4
NCT03990467 UNKNOWN
Septic Shock; Sepsis; Sepsis Syndrome
Hospices Civils de Lyon
2021-01-28
NCT05464680 Recruiting
ARDS|SARS-CoV 2 Pneumonia
Assistance Publique Hopitaux De Marseille
2022-11-24 Not Applicable
NCT05807217 Recruiting
Sepsis|Acute Kidney Injury
Shen Ning|Peking University Third Hospital
2022-10-26 --
NCT03583333 COMPLETED
Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia
Merck Sharp & Dohme LLC
2018-09-18 PHASE3
NCT05060419 UNKNOWN
Complicated Urinary Tract Infection; Acute Pyelonephritis
Qilu Pharmaceutical Co., Ltd.
2021-10-08 PHASE2
NCT04276480 Recruiting
Enterobacteriaceae Infections
University Hospital Bordeaux
2022-02-16 Not Applicable
NCT03862079 WITHDRAWN
Graft-versus-host Disease Prevention
M.D. Anderson Cancer Center
2020-06-01 PHASE2
NCT04233996 UNKNOWN
Febrile Neutropenia
Hospital Universitari de Bellvitge
2019-06-05 PHASE4
NCT03289351 COMPLETED
Perforated Appendicitis; Postoperative Infection
Phoenix Children's Hospital
2017-05-22 PHASE4
NCT03985514 COMPLETED
Appendicitis
Göteborg University
2018-05-15 PHASE4
NCT03485950 COMPLETED
Other Infectious Diseases
M.D. Anderson Cancer Center
2018-05-16 PHASE2
NCT02437045 COMPLETED
Bloodstream Infections
The University of Queensland
2015-04 PHASE4
NCT04394182 SUSPENDED
Pneumonia, Viral; Cytokine Storm
Fundacion GenesisCare
2020-04-21
NCT02991937 COMPLETED
Appendicitis
NYU Langone Health
2016-12 PHASE4
NCT04042077 TERMINATED
Surgical Site Infection
Menarini Group
2019-09-25 PHASE3
NCT03765645 COMPLETED
Antibiotic Prophylaxis; Postoperative Infection
Institute of Liver and Biliary Sciences, India
2018-10-04
NCT03006679 WITHDRAWN
Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia; Hospital-Acquired Pneumonia; Ventilator-Associated Pneumonia
Melinta Therapeutics, Inc.
2018-08 PHASE3
NCT03560232 TERMINATED
Open Fracture; Post-Op Wound Infection
Mercy Health Ohio
2018-07-09 PHASE4
NCT03687255 COMPLETED
Urinary Tract Infections
Allecra
2018-09-24 PHASE3
NCT04895657 COMPLETED
Gram-Negative Infections
Ain Shams University
2018-07-27 PHASE4
NCT03019965 COMPLETED
Sepsis
Coordinación de Investigación en Salud, Mexico
2017-02-01
NCT02493764 COMPLETED
Bacterial Pneumonia
Merck Sharp & Dohme LLC
2015-11-24 PHASE3
NCT02473263 COMPLETED
Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
Assistance Publique - Hôpitaux de Paris
2016-05-09 PHASE3
NCT02466438 UNKNOWN
Infection
St. Justine's Hospital
2016-01 PHASE1
NCT02820987 COMPLETED
Septic Shock
Centre Hospitalier Universitaire de Besancon
2016-09-27 PHASE3
NCT03441529 COMPLETED
Healthy
Janssen Research & Development, LLC
2018-02-09 PHASE1
NCT03376529 COMPLETED
Healthy Volunteers
Spero Therapeutics
2017-11-10 PHASE1
NCT02619149 COMPLETED
Cholecystitis, Acute
Karolinska Institutet
2009-03 PHASE3
NCT02840136 TERMINATED
Cystic Fibrosis
University Ghent
2016-02
NCT02176122 TERMINATED
Bloodstream Infections
The University of Queensland
2014-02 PHASE4
NCT01667094 UNKNOWN
Cystic Fibrosis
The Alfred
2012-09 PHASE4
NCT02463747 UNKNOWN
Fever; Febrile Neutropenia
Tel-Aviv Sourasky Medical Center
2015-06 PHASE4
NCT02191475 UNKNOWN
Abdominal Infection
Tianjin Medical University Cancer Institute and Hospital
2014-05 PHASE2; PHASE3
NCT02817347 TERMINATED
Otitis Media; Otorrhea
Yuhan Corporation
2016-06 PHASE1; PHASE2
NCT01994993 COMPLETED
Complicated Intra Abdominal Infections
Michael Cohen-Wolkowiez
2013-12 PHASE2; PHASE3
NCT02753946 COMPLETED
Urinary Tract Infection Symptomatic; Acute Pyelonephritis; Urinary Tract Infection Complicated
Nabriva Therapeutics AG
2016-04 PHASE2; PHASE3
NCT01796717 UNKNOWN
Nosocomial Pneumonia
Tianjin Medical University Cancer Institute and Hospital
2012-03 PHASE2; PHASE3
NCT02732327 TERMINATED
Neoplasms; Febrile Neutropenia
Forest Laboratories
2016-05-17 PHASE2
NCT01760109 COMPLETED
Respiratory Tract Infections; Urinary Tract Infections
Xiangbei Welman Pharmaceutical Co., Ltd
2011-07 PHASE4
NCT02730624 COMPLETED
Early Phase of Severe Sepsis and Septic Shock
Sutep Jaruratanasirikul
2014-03 PHASE4
NCT02166476 COMPLETED
Urinary Tract Infection Complicated; Acute Pyelonephritis
Melinta Therapeutics, Inc.
2014-11-20 PHASE3
NCT01923363 COMPLETED
Obesity
Loma Linda University
2014-02-25
NCT01897831 UNKNOWN
Respiratory Tract Infections; Urinary Tract Infections
Xiangbei Welman Pharmaceutical Co., Ltd
2011-08 PHASE4
NCT01697059 COMPLETED
Acute Appendicitis
Rhode Island Hospital
2012-09
NCT01714557 UNKNOWN
Neutropenia; Hematopoietic Stem Cell Transplantation
Chinese PLA General Hospital
2012-09
NCT01714570 COMPLETED
Febrile; Neutropenia; Hematopoietic Stem Cell Transplantation
Chinese PLA General Hospital
2012-11
NCT03685084 COMPLETED
Healthy
Allecra
2013-10-10 PHASE1
NCT01577368 COMPLETED
Pseudomonas Aeruginosa Infection
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
2011-05 PHASE3
NCT01370616 COMPLETED
Infection; Diabetic Foot
Merck Sharp & Dohme LLC
2011-09-02 PHASE3
NCT01853982 TERMINATED
Ventilator-Associated Pneumonia (VAP)
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2013-06-14 PHASE3
NCT01694069 TERMINATED
Cystic Fibrosis
West Virginia University
2012-09 PHASE4
NCT01517815 COMPLETED
Septic Shock
University Hospital, Montpellier
2012-02
NCT01198925 COMPLETED
Infectious Disease
University Hospital, Ghent
2010-09-23 PHASE4
NCT00703144 COMPLETED
Diffusive and Convective Clearance; Body Clearance; Piperacillin Tazocilline Concentrations (Cmin)
University Hospital, Toulouse
2008-06 PHASE4
NCT01805856 COMPLETED
Thyroid Disease; Parathyroid Disease
Ito Hospital
2010-11
NCT00629135 COMPLETED
Abscess, Intra-Abdominal
Hannover Medical School
2005-11-15 PHASE3
NCT00816790 TERMINATED
Septic Shock; Acute Renal Failure
Fraser Health
2009-01 PHASE4
NCT01290003 COMPLETED
Neonatal Sepsis
Lady Hardinge Medical College
2010-06
NCT01027832 UNKNOWN
Tracheobronchitis
Assaf-Harofeh Medical Center
2009-09 PHASE2; PHASE3
NCT00873327 COMPLETED
Sepsis
Phillip Brian Smith
2009-10 PHASE1
NCT00894439 COMPLETED
Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer
2009-05 PHASE1
NCT00924742 COMPLETED
Healthy
Tri-Service General Hospital (TSGH)
2009-03
NCT00402727 COMPLETED
Abscess; Wound Infection; Diabetic Foot; Ulcer
Bayer
2006-09 PHASE3
NCT00253955 COMPLETED
Pneumonia
Sanofi
2003-06 PHASE3
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
NCT00044928 COMPLETED
Bacterial Infections
Wyeth is now a wholly owned subsidiary of Pfizer
2002-07 PHASE4
NCT00044746 COMPLETED
Diabetes Mellitus; Diabetic Foot
Wyeth is now a wholly owned subsidiary of Pfizer
2000-10 PHASE4
NCT00003805 COMPLETED
Bone Marrow Suppression; Fever, Sweats, and Hot Flashes; Infection; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
European Organisation for Research and Treatment of Cancer - EORTC
1997-11 PHASE3
NCT00153634 COMPLETED
Cystic Fibrosis; Chronic Bronchitis
Seattle Children's Hospital
2004-03
NCT00236912 TERMINATED
Appendicitis
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2003-07 PHASE4
NCT00438269 COMPLETED
Nosocomial Infection; Pneumonia; Systemic Inflammatory Response Syndrome; Critical Illness; Pyrexia
Canadian Critical Care Trials Group
2003-02 PHASE2
NCT00478855 COMPLETED
Bacterial Infections
Wyeth is now a wholly owned subsidiary of Pfizer
2006-09 PHASE4
NCT00044759 COMPLETED
Hematologic Neoplasms
Wyeth is now a wholly owned subsidiary of Pfizer
PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piperacillin functions by selectively binding to bacterial penicillin-binding proteins, which prevents essential transpeptidation reactions during peptidoglycan cell wall synthesis. This enzymatic inhibition causes cell wall structural weakness and subsequent osmotic cell lysis, leading to bacterial death in critical clinical conditions such as sepsis, severe pneumonia, and abdominal 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.