Sulbactam Clinical Trials

Size	Price	Qty
10mg	USD 79
200mg	USD 370

Clinical Trials

Several Phase IV clinical trials evaluate sulbactam for bacterial conditions, specifically focusing on pneumonia, ventilator-associated pneumonia, and Acinetobacter infections. Sponsored by academic institutions and pharmaceutical companies—including Prince of Songkla University, Hospital Pablo Tobón Uribe, and Pfizer—these investigations examine pharmacodynamic dosing models and combination intravenous therapies. Across this research portfolio, recruitment statuses include both completed and withdrawn studies.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NCT01118403	Withdrawn	Ventilator Associated Pneumonia	Hospital Pablo Tobón Uribe	2011-03	Phase 4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 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulbactam binds to and inhibits bacterial beta-lactamase enzymes with an average IC50 of 0.8 μM, thereby preventing the enzymatic hydrolysis of co-administered beta-lactam antibiotics. This protective activity restores bacterial susceptibility to antimicrobial treatment, providing therapeutic relevance in clinical trial conditions including pneumonia, ventilator-associated 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>).