NCT02607449

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

6.7 years

First QC Date

November 11, 2015

Last Update Submit

May 17, 2022

Conditions

Tuberculosis, MDR

Keywords

TuberculosisMulti-drug resistant TBTB treatment

Outcome Measures

Primary Outcomes (2)

  • Time to persistently negative sputum cultures

    Time from the start of treatment with study drug to the first negative M. tuberculosis sputum culture on solid medium followed by 4 consecutive negative results with an interval of at least 30 days. Measured in months. Estimated population: randomized subjects who took at least 70% of planned study drug doses; having a positive bacterial culture M. tuberculosis at the baseline; who missed less than 2 consecutive visits or less than 14 consecutive days of study drug treatment (modified ITT analysis).

    18 months

  • Proportion of Patients with persistently negative sputum cultures (SCC)

    Sputum culture conversion (SCC) is a persistently negative result of the sputum culture at one year from the patients who had sputum samples positive for growth of M. tuberculosis at baseline and not followed by any positive culture until the end of the trial. SCC corresponds to the outcome "cured" if at least 5 negative bacteriological cultures is recorded (on solid medium) during 12 months with an interval of at least 30 days.

    12 months

Secondary Outcomes (7)

  • The proportion of subjects with relapse of tuberculosis

    12 months

  • Patients body weight dynamics for the period of 18 months.

    18 months

  • The median time to occurrence of negative sputum microscopy result

    18 months

  • The time when TB clinical symptoms not observed

    18 months

  • Dynamics of the tuberculosis process based on subjects chest x-ray diagnosis.

    18 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Drug: FS-1

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).

Drug: Placebo

Interventions

FS-1DRUG

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

A
PlaceboDRUG

Placebo without any active pharmaceutical ingredients

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Semey Medical University

Semey, East Kazakhstan, 071400, Kazakhstan

Location

West Kazakhstan Marat Ospanov Medical University

Aktobe, West Kazakhstan, 030019, Kazakhstan

Location

National scientific center of phthisiopulmonology Ministry of health of the Republic of Kazakhstan

Almaty, 050010, Kazakhstan

Location

Center of Phthisiopulmonology of the Public Health Administration of Almaty

Almaty, 050030, Kazakhstan

Location

Karaganda Medical University

Karaganda, Kazakhstan

Location

National Center of Phthisiatry

Bishkek, 030019, Kyrgyzstan

Location

Related Links

MeSH Terms

Conditions

Tuberculosis, Multidrug-ResistantTuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Amirkan A Azembayev, Cond.Phar.Sc.

    JSC "Scientific Center for Anti-infectious Drugs"

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 18, 2015

Study Start

December 1, 2013

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

KA(5)KY(1)