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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan
• Collaborators: Almaty City Tuberculosis Dispensary, Almaty, Kazakhstan; Invivo laboratory, Kazakhstan; Karaganda Medical University; Ministry of Health, Kazakhstan; National Center of Phthisiatry, Bishkek, Kyrgyzstan; National Scientific Center of Phthisiopulmonology, Kazakhstan; Phthisiopulmonology Center of Almaty, Kazakhstan; Regional Anti-TB Dispensary of Karagandy Oblast, Kazakhstan; Semey State Medical University; West Kazakhstan Marat Ospanov Medical University, Aktobe, Kazakhstan

Criteria

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