Capreomycin Sulfate Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Capreomycin Sulfate is evaluated in several clinical trials investigating tuberculosis and multidrug-resistant tuberculosis, with studies focusing on pharmacokinetic profiles, diagnostic performance—including culture-free targeted sequencing—and treatment regimen effectiveness. Sponsored by academic institutions, non-profit foundations, and public health organizations, these trials report unspecified phases and recruitment statuses that are either completed or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04239326	Completed	Tuberculosis Multidrug-Resistant	Foundation for Innovative New Diagnostics Switzerland	2021-04-16	--
NCT02496572	Unknown status	Multidrug Resistant Tuberculosis	Medecins Sans Frontieres Netherlands\|Ministry of Health Republic of Uzbekistan\|Imperial College London	2013-09	--
NCT02169141	Completed	Tuberculosis	University Medical Center Groningen\|Republican Scientific and Practical Centre for Pulmonology and TB\|National Institute for Public Health and the Environment (RIVM)	2012-11	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Capreomycin sulfate is a cyclic peptide antibiotic that binds to the bacterial 70S ribosomal subunit, thereby disrupting protein synthesis and inhibiting bacterial cell growth. This inhibition of the translational machinery ultimately exerts a bactericidal effect against mycobacteria, providing the mechanistic rationale for its evaluation in clinical trials targeting tuberculosis and multidrug-resistant tuberculosis.

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>).