Silver Sulfadiazine Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A clinical trial evaluated the efficacy of silver sulfadiazine in preventing catheter-related bloodstream infections among patients with hemato-oncological diseases. Sponsored by the Centre National de Greffe de Moelle Osseuse, this completed Phase III study focused directly on infection management and prevention. Overall, this late-stage evaluation demonstrates a targeted approach to reducing severe nosocomial infectious complications in immunocompromised cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00413738	Completed	Infection	Centre National de Greffe de Moelle Osseuse	2006-12	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Silver sulfadiazine dissociates into silver ions that bind bacterial cell membranes and nucleic acids, coupled with sulfadiazine that inhibits bacterial dihydropteroate synthase to disrupt folate biosynthesis. This dual-target mechanism compromises cell wall integrity and inhibits vital metabolic pathways, exerting broad-spectrum bactericidal activity against gram-positive and gram-negative pathogens to effectively control and prevent clinical 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>).