Tazobactam Clinical Trials

Size	Price	Qty
100mg	USD 147
500mg	USD 247

Clinical Trials

Several clinical trials, primarily sponsored by academic medical centers such as University Hospital Grenoble and Assistance Publique Hôpitaux de Marseille, evaluate tazobactam-containing antibacterial regimens across infectious and critical care indications. Ranging from active recruitment to not yet recruiting, these Phase 4, non-phase pharmacokinetic, and observational studies assess treatments for cystic fibrosis, bronchiectasis with Pseudomonas aeruginosa, SARS-CoV-2-associated ARDS, and extended-spectrum beta-lactamase-producing Enterobacteriaceae. Additionally, they investigate beta-lactam pharmacokinetics in patients requiring veno-arterial extracorporeal membrane oxygenation following cardiogenic shock or cardiac surgery.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06338345	Not yet recruiting	Cardiogenic Shock\|Post-cardiac Surgery\|Cardiac Arrest\|Extracorporeal Membrane Oxygenation Complication\|Infections	University Hospital Grenoble	2024-09-01	Not Applicable
NCT06035055	Not yet recruiting	Bronchiectasis\|Cystic Fibrosis\|Pseudomonas Aeruginosa\|Burkholderia Cepacia Infection	Sunshine Coast Hospital and Health Service\|The Prince Charles Hospital\|Mater	2023-10	Phase 4
NCT05464680	Recruiting	ARDS\|SARS-CoV 2 Pneumonia	Assistance Publique Hopitaux De Marseille	2022-11-24	Not Applicable
NCT04276480	Recruiting	Enterobacteriaceae Infections	University Hospital Bordeaux	2022-02-16	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tazobactam covalently binds to and irreversibly inhibits bacterial beta-lactamase enzymes, including class D oxacillinases, thereby preventing the hydrolytic degradation of co-administered beta-lactam antibiotics and restoring their ability to disrupt bacterial cell wall synthesis. This potent inactivation of resistance enzymes restores antibacterial efficacy against beta-lactamase-producing pathogens, providing clinical utility in treating severe respiratory infections, Enterobacteriaceae complications, and pneumonia in critically ill 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>).