Chlorhexidine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate chlorhexidine across indications including hospital-acquired infections, apical periodontitis, neurogenic bladder with urinary retention, and central venous catheter-related bloodstream infections. Encompassing Phase 3 trials and non-phased interventional protocols, these studies are sponsored by academic institutions, university health networks, and industry partners such as Duke University, Yale University, and Irrimax Corporation. Currently in actively recruiting or not yet recruiting stages, these studies investigate chlorhexidine formulations and bathing interventions to mitigate bacterial contamination and prevent catheter-associated infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06112626	Recruiting	Infections	Duke University\|Massachusetts General Hospital\|Indiana University Health	2024-05-01	Not Applicable
NCT06163469	Recruiting	Neurogenic Bladder\|Urinary Retention	Yale University\|Irrimax Corporation	2024-04-01	Not Applicable
NCT03700788	Not yet recruiting	Apical Periodontitis	University of Southern California	2023-05-30	Phase 3
NCT05995080	Recruiting	Central Venous Catheter Related Bloodstream Infection\|Catheter-Related Infections\|Bloodstream Infection Due to Central Venous Catheter	Istanbul Medeniyet University	2022-05-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chlorhexidine binds to negatively charged bacterial cell wall components and lipopolysaccharides, disrupting membrane integrity, inducing leakage of intracellular constituents, and precipitating cytoplasmic proteins. This potent broad-spectrum anti-infective activity leads to rapid microbial lysis, providing essential protection against catheter-related bloodstream infections, endodontic pathogens, and topical bacterial contamination in clinical settings.

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>).