Sulfadiazine Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

The clinical research landscape for sulfadiazine includes a clinical trial recorded in public registry databases. Sponsored by the academic institution Centre National de Greffe de Moelle Osseuse, this completed Phase 3 study evaluated prophylactic antimicrobial strategies to prevent and manage catheter-related bloodstream infections in immunocompromised patients with hemato-oncological disease. The investigation aimed to reduce severe infectious complications associated with indwelling vascular catheters during oncology treatments.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulfadiazine competitively inhibits bacterial dihydropteroate synthase, blocking the incorporation of para-aminobenzoic acid into dihydropteroic acid and disrupting downstream folic acid synthesis necessary for purine biosynthesis. This suppression of essential nucleotide production inhibits bacterial cell growth and replication, providing the therapeutic rationale for preventing and treating catheter-related systemic infections in patients.

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>).