Cloxacillin Sodium Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic application and pharmacokinetics of cloxacillin sodium across conditions such as infective endocarditis, combination-treatment-associated acute kidney injury, and methicillin-susceptible Staphylococcus aureus bacteremia. Sponsored by academic medical centers—specifically University Hospital Strasbourg, Uppsala University, and Assistance Publique - Hôpitaux de Paris—these studies feature unassigned or not applicable phase designs. Current recruitment statuses across these trials encompass active not recruiting, recruiting, and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05142891	Unknown status	Endocarditis\|Acute Kidney Injury	University Hospital Strasbourg France	2021-10-15	--
NCT04647331	Recruiting	Infective Endocarditis	Uppsala University	2021-06-01	--
NCT03248063	Active not recruiting	Bacteremia Due to Methicillin Susceptible Staphylococcus Aureus	Assistance Publique - Hôpitaux de Paris	2018-09-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cloxacillin sodium binds to penicillin-binding proteins to inhibit the cross-linking step of bacterial cell wall peptidoglycan biosynthesis, resulting in cell wall weakening and osmotic lysis during active bacterial cell division. This bactericidal activity effectively eradicates susceptible Gram-positive pathogens, providing the therapeutic rationale for its clinical evaluation in severe staphylococcal infections such as infective endocarditis and methicillin-susceptible Staphylococcus aureus bacteremia.

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>).