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.
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>).
- Piperacillin Sodium Solubility in DMSO
- Piperacillin Sodium Stock Solution
- Piperacillin Sodium Storage
- Piperacillin Sodium Stability
- Piperacillin Sodium Molecular Weight
- Piperacillin Sodium SMILES
- Piperacillin Sodium CAS Number
- Piperacillin Sodium Chemical Structure (2D and 3D)
- Piperacillin Sodium SDS|MSDS
Note: Technical data last updated: Sep 1, 2026.