Clinical Trials

Numerous clinical trials evaluate cefixime across various indications, including bacterial infections, female syphilis, liver abscesses, typhoid fever, gonorrhoea, acute uncomplicated pyelonephritis, drug hypersensitivity, and pediatric solid tumors. Ranging from Phase 1 to Phase 4 alongside non-applicable classifications, these studies present diverse recruitment statuses from completed and active to withdrawn, terminated, or unknown. The trial portfolio is sponsored by pharmaceutical companies, global organizations such as the World Health Organization, and prominent clinical research institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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
NCT04958122 RECRUITING
Syphilis; Human Immunodeficiency Virus
University of Southern California
 2021-06-20 PHASE3
NCT06847126 RECRUITING
Liver Abscess
Post Graduate Institute of Medical Education and Research, Chandigarh
 2025-02-25 PHASE3
NCT05294588 COMPLETED
Gonorrhea Male
University of North Carolina, Chapel Hill
 2022-04-18 PHASE2
NCT04349826 COMPLETED
Typhoid Fever
Oxford University Clinical Research Unit, Vietnam
 2021-05-23 PHASE4
NCT06907316 TERMINATED
Syphilis
Bulovka Hospital
 2021-07-13 PHASE4
NCT05027893 UNKNOWN
Postoperative Complications; Antibiotic Reaction; Antibiotic Side Effect; Antibiotic Resistant Infection; Antibiotic Resistant Strain; Infection, Bacterial; Infection, Laboratory
University of Novi Sad
 2019-06-07
NCT06090565 COMPLETED
Gonorrhea
Bulovka Hospital
 2021-04-01 PHASE4
NCT05216744 COMPLETED
Neisseria Gonorrhoeae Infection; Chlamydia Trachomatis Infection
Haiphong University of Medicine and Pharmacy
 2021-07-15 PHASE2
NCT05507736 Recruiting
Pediatric Cancer|Solid Tumor
Fundació Sant Joan de Déu
 2022-01-15 Not Applicable
NCT03752112 UNKNOWN
Syphilis Female
World Health Organization
 2019-11-22 PHASE1; PHASE2
NCT03660488 COMPLETED
Syphilis; Early Syphilis
University of California, Los Angeles
 2018-09-03 PHASE2
NCT04982861 COMPLETED
Drug Use
PT Bernofarm
 2020-06-15
NCT03969758 UNKNOWN
Liver Abscess
Post Graduate Institute of Medical Education and Research, Chandigarh
 2019-07 PHASE3
NCT02021006 UNKNOWN
Vesicoureteral Reflux; Renal Hypodysplasia, Nonsyndromic, 1; Chronic Kidney Disease
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
 2013-12 PHASE3
NCT03840811 COMPLETED
Gonococcal Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-04-23 PHASE1
NCT03752112 Unknown status
Syphilis Female
World Health Organization
 2019-11-22 Phase 1|Phase 2
NCT03969758 Unknown status
Liver Abscess
Post Graduate Institute of Medical Education and Research Chandigarh|PGIMER
 2019-07 Phase 3
NCT01595529 COMPLETED
Urinary Tract Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2012-05-18 PHASE2
NCT02596503 COMPLETED
Relapsed Solid Tumors; Refractory Solid Tumors
University of Colorado, Denver
 2015-10-21 PHASE1
NCT03716804 COMPLETED
Uncomplicated Urinary Tract Infection; Antibiotic Resistant Infection
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2018-06-06 PHASE4
NCT03408392 COMPLETED
Infections, Bacterial
GlaxoSmithKline
 2018-02-06 PHASE1
NCT03329547 WITHDRAWN
Infections, Bacterial
GlaxoSmithKline
 2018-01-11 PHASE1
NCT03408392 Completed
Infections Bacterial
GlaxoSmithKline
 2018-02-06 Phase 1
NCT03329547 Withdrawn
Infections Bacterial
GlaxoSmithKline
 2018-01-11 Phase 1
NCT02830230 UNKNOWN
Cervical Inflammation and Human Papilloma Virus Performance
Tata Memorial Hospital
 2016-07
NCT02708992 COMPLETED
Gonorrhoea
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-04-28 PHASE1
NCT01949363 COMPLETED
Gonorrhoea
National Institute of Allergy and Infectious Diseases (NIAID)
 2013-12 PHASE1
NCT02224040 UNKNOWN
Typhoid Fever
Sheba Medical Center
 2013-08 PHASE4
NCT01390623 COMPLETED
Acute Uncomplicated Pyelonephritis
University Hospital, Clermont-Ferrand
 2011-07 PHASE4
NCT00786669 COMPLETED
Solid Tumor
Children's Hospital Medical Center, Cincinnati
 2008-10 PHASE1
NCT01072136 TERMINATED
Vaginitis Bacterial; Cervicitis
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-03 PHASE3
NCT00186979 COMPLETED
Solid Tumors
St. Jude Children's Research Hospital
 2003-05 PHASE1
NCT00136656 COMPLETED
Pyelonephritis
Assistance Publique - Hôpitaux de Paris
 2005-07 PHASE4
NCT00093353 COMPLETED
Diarrhea; Drug/Agent Toxicity by Tissue/Organ; Neuroblastoma
New Approaches to Neuroblastoma Therapy Consortium
 2004-05 PHASE1
NCT00004216 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Vion Pharmaceuticals
 1999-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefixime binds to and inactivates penicillin-binding proteins located on the inner membrane of susceptible bacterial cell walls. This binding blocks peptidoglycan cross-linking and disrupts structural cell wall synthesis, leading to osmotic lysis and cell death, which underlies its therapeutic efficacy in treating clinical conditions such as gonorrhoea, uncomplicated pyelonephritis, and typhoid fever.

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.