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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2020-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tuberculosis, MDR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

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.

Group Type EXPERIMENTAL

FS-1

Intervention Type DRUG

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

B

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo without any active pharmaceutical ingredients

Interventions

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FS-1

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

Intervention Type DRUG

Placebo

Placebo without any active pharmaceutical ingredients

Intervention Type DRUG

Eligibility Criteria

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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;

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No