Colistin Sulfate Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials are evaluating colistin across various clinical settings, primarily investigating nosocomial infections, hospital-acquired bacterial pneumonia, ventilator-associated pneumonia, and gram-negative bacterial infections. These studies encompass Phase 2, Phase 4, and phase not applicable classifications, sponsored by biopharmaceutical entities and academic medical institutions. Across these trials, recruitment statuses include not yet recruiting, terminated, and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06087536	Not yet recruiting	Hospital-acquired Bacterial Pneumonia\|Ventilator-associated Bacterial Pneumonia	Omnix Medical Ltd	2024-01	Phase 2
NCT05542446	Terminated	Colistin	St. Anne''s University Hospital Brno Czech Republic\|Palacky University	2022-09-01	Phase 4
NCT04775238	Unknown status	Nosocomial Infections	Sohag University	2021-02-27	Not Applicable
NCT04208945	Unknown status	Pneumonia Ventilator-associated\|Gram-Negative Pneumonia	University of Thessaly	2019-12	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Colistin electrostatically binds to lipopolysaccharides and phospholipids in the outer membrane of Gram-negative bacteria, displacing divalent calcium and magnesium ions to disrupt membrane stability and cause intracellular leakage leading to bacterial cell death. This rapid bactericidal disruption of the outer bacterial membrane provides the mechanistic basis for treating severe Gram-negative infections, such as hospital-acquired and ventilator-associated bacterial pneumonia.

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>).