Aztreonam Clinical Trials

Size	Price	Qty
50mg	USD 147
500mg	USD 470

Clinical Trials

Multiple clinical trials evaluate aztreonam across Phase 1, Phase 2, and Phase 2/3 designs, alongside unclassified protocols sponsored by pharmaceutical entities such as Pfizer and Gilead Sciences as well as academic institutions. These studies assess pharmacokinetic parameters in healthy participants and individuals with renal insufficiency, in addition to therapeutic indications including adult bronchiectasis, pharyngeal gonorrhea, and nosocomial bacterial infections. Recruitment statuses across these trials range from completed and actively recruiting to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04973826	Completed	Healthy	Pfizer	2021-08-20	Phase 1
NCT04775238	Unknown status	Nosocomial Infections	Sohag University	2021-02-27	Not Applicable
NCT04486625	Completed	Renal Insufficiency	Pfizer	2020-08-10	Phase 1
NCT03696290	Recruiting	Bronchiectasis Adult	University of Dundee\|Gilead Sciences	2019-10-19	Phase 2
NCT03867734	Completed	Gonorrhea of Pharynx\|Gonorrhea	University of Washington	2019-04-05	Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aztreonam selectively binds with high affinity to penicillin-binding protein 3 (PBP-3) in susceptible bacteria, inhibiting mucopeptide synthesis and preventing peptidoglycan crosslinking required for cell wall integrity. This disruption leads to filamentous elongation, cell wall lysis, and bacterial death, providing targeted bactericidal efficacy relevant to clinical settings such as adult bronchiectasis, pharyngeal gonorrhea, and severe nosocomial Gram-negative 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>).