Clinical Trials

Cefepime Dihydrochloride Monohydrate has undergone evaluation across numerous clinical trials spanning Phase 1 through Phase 4, supported by both academic institutions and industry sponsors. These studies focus on conditions including pneumonia, complicated urinary tract infections, skin and soft tissue infections, and febrile neutropenia, alongside specialized evaluations of intrapulmonary pharmacokinetics, renal impairment, and hypersensitivity reactions. Protocol statuses across this research record encompass completed, active, recruiting, and terminated clinical studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05826990 RECRUITING
Complicated Urinary Tract Infection
Orchid Pharma Europe GmbH
 2023-09-11 PHASE2
NCT06954129 RECRUITING
Acute Kidney Injury
University of Pennsylvania
 2026-01-28 PHASE4
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
NCT07484633 NOT_YET_RECRUITING
Infection; Sepsis; NICU; PICU; Beta Lactams
Semmelweis University
 2026-04 PHASE4
NCT06168734 WITHDRAWN
Ventilator-associated Pneumonia; Hospital-acquired Pneumonia
Venatorx Pharmaceuticals, Inc.
 2025-06 PHASE3
NCT03078010 ACTIVE_NOT_RECRUITING
Intestinal Microbiome; Febrile Neutropenia
Memorial Sloan Kettering Cancer Center
 2017-02-10 PHASE2
NCT03630081 UNKNOWN
Complicated Urinary Tract Infection; Acute Pyelonephritis
Wockhardt
 2024-01 PHASE3
NCT04948463 COMPLETED
Febrile Neutropenia
Murdoch Childrens Research Institute
 2021-11-15 PHASE4
NCT05905055 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Complicated Intra-abdominal Infection
Meiji Seika Pharma Co., Ltd.
 2023-09-22 PHASE3
NCT06806995 COMPLETED
PHA1A
Wockhardt
 2025-01-21 PHASE1
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
NCT04979806 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis
Wockhardt
 2022-08-28 PHASE3
NCT05887908 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis; cUTI; AP
Meiji Seika Pharma Co., Ltd.
 2023-05-23 PHASE3
NCT05156437 TERMINATED
Endocarditis
West Virginia University
 2022-03-16 PHASE4
NCT05079620 TERMINATED
Aspiration; Aspiration Pneumonia
UConn Health
 2021-11-30 PHASE4
NCT04983901 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2021-09-14 PHASE2
NCT06048692 UNKNOWN
Cesarean Section; Infection
Beni-Suef University
 2023-01-01 PHASE3
NCT04816968 UNKNOWN
Severe Bacterial Infections
Ospedale San Carlo Borromeo
 2021-09 PHASE1
NCT05102162 TERMINATED
Pneumonia
University of Florida
 2021-12-17 PHASE4
NCT05588531 COMPLETED
Pharmacokinetics
Nanjing Yoko Biomedical Co., Ltd.
 2021-12-20 PHASE1
NCT04233996 UNKNOWN
Febrile Neutropenia
Hospital Universitari de Bellvitge
 2019-06-05 PHASE4
NCT03840148 COMPLETED
Urinary Tract Infections; Acute Pyelonephritis
Venatorx Pharmaceuticals, Inc.
 2019-08-07 PHASE3
NCT04951505 COMPLETED
Healthy Subjects
Venatorx Pharmaceuticals, Inc.
 2021-06-29 PHASE1
NCT03485950 COMPLETED
Other Infectious Diseases
M.D. Anderson Cancer Center
 2018-05-16 PHASE2
NCT04009772 UNKNOWN
Emergency Cesarean Section; Infection Wound
Assiut University
 2019-07-01 PHASE2; PHASE3
NCT03687255 COMPLETED
Urinary Tract Infections
Allecra
 2018-09-24 PHASE3
NCT04187755 COMPLETED
Neutropenia, Febrile; Leukemia; Pediatric Cancer; Antibiotic Reaction
Indonesia University
 2019-03-01 PHASE4
NCT03680378 COMPLETED
Healthy Subjects
Allecra
 2017-07-01 PHASE1
NCT03870490 COMPLETED
Healthy Subjects
Venatorx Pharmaceuticals, Inc.
 2019-03-14 PHASE1
NCT03680352 COMPLETED
PK in Patients With Various Degrees of Renal Impairment
Allecra
 2017-09-01 PHASE1
NCT02820987 COMPLETED
Septic Shock
Centre Hospitalier Universitaire de Besancon
 2016-09-27 PHASE3
NCT02688582 COMPLETED
Antimicrobial Treatment
Onze Lieve Vrouw Hospital
 2016-03-01
NCT03680612 COMPLETED
Urinary Tract Infections
Allecra
 2017-09-05 PHASE2
NCT02497781 COMPLETED
Complicated Urinary Tract Infections
Pfizer
 2015-09-24 PHASE2
NCT01667094 UNKNOWN
Cystic Fibrosis
The Alfred
 2012-09 PHASE4
NCT03630094 COMPLETED
PHA1A
Wockhardt
 2017-03-31 PHASE1
NCT02872038 COMPLETED
Peritoneal Dialysis Associated Peritonitis
Chulalongkorn University
 2015-08 PHASE4
NCT02709382 COMPLETED
Renal Impairment
Wockhardt
 2016-03 PHASE1
NCT02732327 TERMINATED
Neoplasms; Febrile Neutropenia
Forest Laboratories
 2016-05-17 PHASE2
NCT02707107 COMPLETED
Serious Gram-negative Infections
Wockhardt
 2016-03 PHASE1
NCT02568800 UNKNOWN
Urinary Tract Infection; Respiratory Tract Infection
Hospital de Clinicas de Porto Alegre
 2015-10 PHASE3
NCT02302092 TERMINATED
Urinary Tract Infection
Takeda
 2015-12-01 PHASE3
NCT01852630 COMPLETED
Spontaneous Bacterial Peritonitis
Institute of Liver and Biliary Sciences, India
 2012-12
NCT02532140 COMPLETED
Healthy
Wockhardt
 2015-08 PHASE1
NCT02680600 COMPLETED
Antimicrobial Treatment
Onze Lieve Vrouw Hospital
 2014-03
NCT03685084 COMPLETED
Healthy
Allecra
 2013-10-10 PHASE1
NCT01110408 TERMINATED
Complicated Urinary Tract Infections or Pyelonephritis
Janssen Research & Development, LLC
 2010-12 PHASE3
NCT01484015 COMPLETED
Adult Acute Lymphoblastic Leukemia; Adult Acute Myeloid Leukemia; Adult Burkitt Lymphoma; Adult Diffuse Large Cell Lymphoma; Adult Diffuse Mixed Cell Lymphoma; Adult Diffuse Small Cleaved Cell Lymphoma; Adult Hodgkin Lymphoma; Adult Immunoblastic Large Cell Lymphoma; Adult Lymphoblastic Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Breast Cancer; Chronic Eosinophilic Leukemia; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Cutaneous T-cell Non-Hodgkin Lymphoma; Disseminated Neuroblastoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3 Follicular Lymphoma; Malignant Testicular Germ Cell Tumor; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Multiple Myeloma; Mycosis Fungoides/Sezary Syndrome; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neutropenia; Nodal Marginal Zone B-cell Lymphoma; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Plasma Cell Neoplasm; Poor Prognosis Metastatic Gestational Trophoblastic Tumor; Primary Myelofibrosis; Prolymphocytic Leukemia; Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma
Wake Forest University Health Sciences
 2011-02 PHASE1
NCT01110421 TERMINATED
Pneumonia, Bacterial; Community-Acquired Infections; Nosocomial Infection; Pneumonia, Ventilator-Associated
Janssen Research & Development, LLC
 2010-12 PHASE3
NCT00137787 COMPLETED
Febrile Neutropenia
Center for Supporting Hematology-Oncology Trials
 2005-04 PHASE3
NCT00529282 TERMINATED
Fever; Neutropenia; Gram-positive Bacterial Infections; Pseudomonas Infection
Basilea Pharmaceutica
 2007-10 PHASE3
NCT00609375 COMPLETED
Sepsis; Bacteremia
Javeriana University
 2006-09 PHASE4
NCT00358202 COMPLETED
Pneumonia
CPL Associates
 2002-03 PHASE4
NCT00020865 UNKNOWN
Fever, Sweats, and Hot Flashes; Infection; Leukemia; Lymphoma; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
Jonsson Comprehensive Cancer Center
 2001-09 PHASE3
NCT00044759 COMPLETED
Hematologic Neoplasms
Wyeth is now a wholly owned subsidiary of Pfizer
 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Cefepime Dihydrochloride Monohydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefepime binds to and inhibits bacterial penicillin-binding proteins, which disrupts peptidoglycan cross-linking during cell wall synthesis and leads to osmotic instability and bacterial cell lysis. This bactericidal mechanism directly correlates with its clinical effectiveness in treating severe bacterial conditions, such as pneumonia, complicated urinary tract infections, and skin and soft tissue infections investigated in clinical trials.

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.