Sulbactam sodium Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple Phase 4 clinical trials evaluate the efficacy, pharmacodynamic dosing regimens, and combination antibiotic therapies of sulbactam sodium in treating severe bacterial infections, including Acinetobacter infections, pneumonia, and ventilator-associated pneumonia. Sponsored by academic and clinical entities such as Prince of Songkla University and Hospital Pablo Tobón Uribe, alongside pharmaceutical industry support from Pfizer, these studies have recruitment statuses ranging from completed investigations to withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02688322	Completed	Acinetobacter Infections	Sutep Jaruratanasirikul\|Prince of Songkla University	2014-09	Phase 4
NCT01118403	Withdrawn	Ventilator Associated Pneumonia	Hospital Pablo Tobón Uribe	2011-03	Phase 4
NCT00137007	Completed	Pneumonia	Pfizer	2003-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulbactam sodium acts as an irreversible β-lactamase inhibitor that covalently binds to β-lactamase enzymes, preventing enzymatic hydrolysis and degradation of co-administered β-lactam antibiotics. By restoring bacterial susceptibility to β-lactam agents, this inhibition suppresses enzyme-mediated resistance in pathogenic organisms, demonstrating clinical utility in treating bacterial infections such as pneumonia and Acinetobacter 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>).