Streptomycin sulfate Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate streptomycin sulfate across Phase 1 to Phase 4 for bacterial infections, including pulmonary and multidrug-resistant tuberculosis, bubonic and pneumonic plague, Buruli ulcer caused by *Mycobacterium ulcerans*, and surgical site infections following colorectal surgery. Encompassing early safety and pharmacokinetic assessments in healthy subjects alongside therapeutic evaluations, these studies are sponsored by academic institutions, non-profit foundations, and government entities such as the US CDC. The majority of these trials have reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04110340	COMPLETED	Plague, Bubonic; Plague, Pneumonic	University of Oxford	2020-02-15	PHASE3
NCT04239326	Completed	Tuberculosis Multidrug-Resistant	Foundation for Innovative New Diagnostics Switzerland	2021-04-16	--
NCT02065245	COMPLETED	Frailty	Longeveron Inc.	2014-03-03	PHASE1; PHASE2
NCT01659437	COMPLETED	Mycobacterium Ulcerans Infection	University Medical Center Groningen	2012-12	PHASE2; PHASE3
NCT01432925	COMPLETED	Mycobacterium Ulcerans Disease; Buruli Ulcer	University Medical Center Groningen	2011-09
NCT02331823	UNKNOWN	Reinfection Pulmonary Tuberculosis	Shanghai Pulmonary Hospital, Shanghai, China	2013-06	PHASE4
NCT02128308	COMPLETED	Healthy	Seoul National University Hospital	2013-11	PHASE1
NCT00321178	COMPLETED	Buruli Ulcer; Mycobacterium Ulcerans	University Medical Center Groningen	2006-05	PHASE2; PHASE3
NCT00023374	Completed	Tuberculosis	Centers for Disease Control and Prevention\|US Department of Veterans Affairs	2000-08	Not Applicable
NCT00004444	COMPLETED	Tuberculosis, Pulmonary	FDA Office of Orphan Products Development	1994-11
NCT00128466	COMPLETED	Plague	Centers for Disease Control and Prevention	2004-08	PHASE2; PHASE3
NCT00000796	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00004689	COMPLETED	Mycobacterium Avium-intracellulare Infection	National Jewish Health	1991-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-03-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Streptomycin sulfate selectively binds to the S12 protein of the bacterial 30S ribosomal subunit, interfering with formyl-methionyl-tRNA binding and inducing mRNA misreading, which prevents bacterial protein synthesis initiation and leads to microbial cell death. This potent bactericidal action provides the biological rationale for its broad-spectrum therapeutic efficacy against bacterial infections evaluated in clinical trials, such as tuberculosis, plague, and Buruli ulcer.

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>).