Vancomycin HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 590

Clinical Trials

Several clinical trials are evaluating Vancomycin HCl across applications such as community-acquired pneumonia, infection prevention following anterior cruciate ligament injuries, and pharmacokinetic dosing individualization. Sponsored by academic and medical institutions including Vanderbilt University Medical Center, Assiut University, and Erasmus Medical Center, these studies feature non-traditional or unassigned phase designations. With active statuses ranging from enrolling by invitation to not yet recruiting, these ongoing investigations aim to optimize empiric antibacterial therapy and refine patient dosing accuracy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06272994	Enrolling by invitation	Community-acquired Pneumonia	Vanderbilt University Medical Center	2024-04-03	Not Applicable
NCT06050785	Not yet recruiting	Anterior Cruciate Ligament Injuries	Assiut University	2024-02-01	--
NCT05964114	Not yet recruiting	Vancomycin\|Pharmacokinetics	Erasmus Medical Center	2023-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vancomycin HCl binds specifically to the D-alanyl-D-alanine terminus of cell wall peptidoglycan precursors, preventing the incorporation of N-acetylmuramic acid and N-acetylglucosamine peptide subunits into the peptidoglycan matrix and thereby inhibiting bacterial cell wall synthesis. This targeted disruption leads to osmotic cell lysis and bacterial death, rendering the agent clinically effective for managing Gram-positive infections such as community-acquired pneumonia and preventing surgical site contamination during graft procedures.

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>).