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
StatusCompleted No Results Posted
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.
FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.
Placebo without any active pharmaceutical ingredients
Standard TB treatment + treatment regiment with a placebo. Instead of study drug the placebo was given to the patients orally once per day along with other prescribed TB drugs (in quntity equal to study drug).
Standard TB treatment+ treatment regiment with FS-1 drug. Study drug was given to the patients orally once per day in dose of 2.5 mg/kg along with other prescribed TB drugs.
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