Trial | NCT02607449  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Efesovir ...

  • Study Participants

    344
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.
Study Started
Dec 31
2013
Primary Completion
Aug 31
2020
Study Completion
Oct 31
2020
Last Update
May 24
2022

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

A Experimental

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.

B Placebo Comparator

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).

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
No Results Posted