Oxacillin sodium monohydrate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials evaluate conditions including multi-antibiotic resistance, bloodstream infections, asymptomatic pharyngeal carriage of Neisseria gonorrhoeae, Candida auris colonization, and bacterial carriage in sickle cell disease. Sponsored primarily by academic centers, medical networks, and research organizations—such as Assistance Publique - Hôpitaux de Paris, Rush University Medical Center, and ANRS Emerging Infectious Diseases—these studies encompass Phase 2, Phase 3, Phase 4, and unclassified developmental stages. Recruitment statuses across these investigations vary, ranging from currently recruiting and active to completed or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06282510	Recruiting	Candida Auris Infection\|Colonization Asymptomatic	Mary K Hayden\|Rush University Medical Center\|RML Specialty Hospital	2024-01-29	Phase 4
NCT05971550	Not yet recruiting	Neisseria Gonorrhoeae Infection\|Asymptomatic Pharyngeal Carriage	Assistance Publique - Hôpitaux de Paris	2023-09	Phase 3
NCT05100407	Completed	Multi-antibiotic Resistance	Kufa University	2022-03-01	--
NCT05197205	Unknown status	Sickle Cell Disease	Assistance Publique - Hôpitaux de Paris	2022-02-01	Not Applicable
NCT04597424	Active not recruiting	Unsafe Sex\|Risk-Taking	ANRS Emerging Infectious Diseases	2021-01-19	Phase 3
NCT03869437	Completed	Bloodstream Infections	The University of Queensland\|Shionogi	2019-10-28	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxacillin sodium monohydrate selectively binds to bacterial penicillin-binding proteins, effectively inhibiting the transpeptidase activity required for peptidoglycan cross-linking during cell wall synthesis. This biochemical blockade compromises cell wall integrity and triggers osmotic cell lysis, providing the mechanistic rationale for clinical evaluations in managing bacterial carriage, multi-antibiotic resistance, and bloodstream infections.

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>).