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

Randomized, Placebo-controlled Study of Safety and Therapeutic Efficacy of the Drug FS-1 in the Oral Dosage Form in Drug-resistant Pulmonary Tuberculosis

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).

Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter, placebo-controlled (add-on), double-blind and two arms trial.

The study consists of two following phases: treatment phase - 6 months and follow-up phase 12 months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.

All data will be compiled in an Electronic Data Capture System with further statistical analysis according to approved Statistical Analytical Plan.

Inclusion Criteria:

• Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:

  • MDR Tuberculosis confirmed by microbiology test at screening.
  • resistance to isoniazid and rifampicin demonstrated by drug susceptibility test
  • susceptiblity of TB bacteria to fluoroquinolones and aminoglycoside/capreomycin

• all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol

• Willing to freely and voluntarily give signed informed consent

• Willing and capable to comply with all requirements of the protocol

Exclusion Criteria:

• Pregnancy and breast-feeding;
• Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
• Severe mental disorders;
• Allergy to iodine-containing drugs, hypersensitivity to iodine;
• Intolerance to second-line drugs;
• Epidermomycosis
• Socially maladjusted patients suffering from alcoholism and drug addiction;
• Hypothyroidism;
• Hashimoto's thyroiditis;
• TB treatment for more than two months before the start of the study;
• Not willing to adhere to TB therapy;

Exclusion Criteria during the study:

• at the discretion of the researcher, if the continuation of the study is harmful to the patient;
• side effects related with the study drug
• patient's decision to stop participation in study
• appearance of any exclusion criteria during study