Cefotaxime Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate cefotaxime across pharmacological and infectious disease contexts, including infective endocarditis, acute otitis media with mastoiditis, and genetic variations in transporter-mediated renal secretion. These Phase 1 and unspecified phase studies, sponsored by academic and commercial entities such as Uppsala University, Pfizer, and the University of California, San Francisco, encompass both completed research and actively recruiting beta-lactam pharmacokinetics trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04647331	Recruiting	Infective Endocarditis	Uppsala University	2021-06-01	--
NCT01272999	Completed	Acute Otitis Media\|Mastoiditis	Pfizer	2010-05-21	--
NCT00187655	Completed	Focus Groups	University of California San Francisco	2004-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cefotaxime is a third-generation cephalosporin antibiotic that selectively binds to and inhibits penicillin-binding proteins, thereby suppressing the final transpeptidation step of bacterial peptidoglycan cell wall synthesis and causing osmotic cell lysis. By compromising bacterial cell wall integrity across a broad spectrum of Gram-positive and Gram-negative pathogens, cefotaxime exerts potent bactericidal activity relevant to treating severe bacterial infections such as infective endocarditis and acute otitis media.

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>).