FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis

NCT02607449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2022-05-24

No results posted yet for this study

Summary

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, the Government of the Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to treat drug-resistant forms of this infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).

Conditions

  • Tuberculosis, MDR

Interventions

DRUG

FS-1

FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.

DRUG

Placebo

Placebo without any active pharmaceutical ingredients

Sponsors & Collaborators

  • Phthisiopulmonology Center of Almaty, Kazakhstan

    collaborator UNKNOWN
  • National Scientific Center of Phthisiopulmonology, Kazakhstan

    collaborator UNKNOWN
  • Karaganda Medical University

    collaborator OTHER
  • West Kazakhstan Marat Ospanov Medical University, Aktobe, Kazakhstan

    collaborator UNKNOWN
  • Semey State Medical University

    collaborator OTHER
  • National Center of Phthisiatry, Bishkek, Kyrgyzstan

    collaborator OTHER
  • Invivo laboratory, Kazakhstan

    collaborator UNKNOWN
  • Scientific Center for Anti-infectious Drugs, Kazakhstan

    lead INDUSTRY

Principal Investigators

  • Amirkan A Azembayev, Cond.Phar.Sc. · JSC "Scientific Center for Anti-infectious Drugs"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2020-08-31
Completion
2020-10-31

Countries

  • Kazakhstan
  • Kyrgyzstan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02607449 on ClinicalTrials.gov