Clinical trial NCT02607449: FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
Official title: Randomized, Placebo-controlled Study of Safety and Therapeutic Efficacy of the Drug FS-1 in the Oral Dosage Form in Drug-resistant Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis, MDR
Keywords: Tuberculosis
Multi-drug resistant TB
TB treatment
Lead sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan
Sponsor class: INDUSTRY
Collaborators: name: Phthisiopulmonology Center of Almaty, Kazakhstan
name: National Scientific Center of Phthisiopulmonology, Kazakhstan
name: Karaganda Medical University
name: West Kazakhstan Marat Ospanov Medical University, Aktobe, Kazakhstan
name: Semey State Medical University
name: National Center of Phthisiatry, Bishkek, Kyrgyzstan
name: Invivo laboratory, Kazakhstan
First posted: 2015-11-18
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Time to persistently negative sputum cultures
timeFrame: 18 months
measure: Proportion of Patients with persistently negative sputum cultures (SCC)
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of subjects with relapse of tuberculosis
timeFrame: 12 months
measure: Patients body weight dynamics for the period of 18 months.
timeFrame: 18 months
measure: The median time to occurrence of negative sputum microscopy result
timeFrame: 18 months
measure: The time when TB clinical symptoms not observed
timeFrame: 18 months
measure: Dynamics of the tuberculosis process based on subjects chest x-ray diagnosis.
timeFrame: 18 months
measure: The incidence and severity of Adverse Events, Serious Adverse Events and drug related Adverse Drug Reactions
timeFrame: 18 months
measure: Assessment of the study drug effect on thyroid gland function
timeFrame: 18 months
Other outcomes:
Locations:
city: Semey
country: Kazakhstan
facility: Semey Medical University
state: East-Kazakhstan Region
city: Aktobe
country: Kazakhstan
facility: West Kazakhstan Marat Ospanov Medical University
state: West Kazakhstan Region
city: Almaty
country: Kazakhstan
facility: National scientific center of phthisiopulmonology Ministry of health of the Republic of Kazakhstan
city: Almaty
country: Kazakhstan
facility: Center of Phthisiopulmonology of the Public Health Administration of Almaty
city: Karaganda
country: Kazakhstan
facility: Karaganda Medical University
city: Bishkek
country: Kyrgyzstan
facility: National Center of Phthisiatry
Study officials:
affiliation: JSC "Scientific Center for Anti-infectious Drugs"
name: Amirkan A Azembayev, Cond.Phar.Sc.
role: STUDY_DIRECTOR
References: