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

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ClinicalTrials.gov Identifier: NCT02607449
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
National Center of Phthisiatry, Bishkek, Kyrgyzstan
Ministry of Health, Kazakhstan
Almaty City Tuberculosis Dispensary, Almaty, Kazakhstan
Regional Anti-TB Dispensary of Karagandy Oblast, Kazakhstan
Karaganda State Medical University, Karaganda, Kazakhstan
Information provided by (Responsible Party):
Scientific Center for Anti-infectious Drugs, Kazakhstan

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).

Condition or disease Intervention/treatment Phase
Tuberculosis, MDR Drug: FS-1 Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: A
Standard DOTS+ treatment regiment with FS-1 drug.
Drug: FS-1
FS-1 is a liquid solution for internal intake and bears antimicrobial and antibacterial activities.

Placebo Comparator: B
Standard DOTS+ treatment regiment with a placebo.
Drug: Placebo
Placebo without any active pharmaceutical ingredients




Primary Outcome Measures :
  1. Proportion of Patients with persistently negative sputum cultures (SCC) [ Time Frame: up to 12 months ]
    persistently negative sputum cultures (SCC) at one year who had sputum samples positive for growth of M. tuberculosis at baseline. [Persistent SCC is defined as a sputum specimen from a subject who becomes negative for growth of M. tuberculosis using the MGIT culture system at any time following initiation of treatment, followed by at least five confirmatory negative culture at least 30 days after the first negative sputum, and not followed by any positive culture until the end of the trial.]


Secondary Outcome Measures :
  1. The proportion of subjects with relapse of tuberculosis [ Time Frame: up to 12 months ]
  2. Change of body weight [ Time Frame: up to 18 months ]
  3. The median time to occurrence of negative sputum cultures (SCC). [ Time Frame: up to 12 months ]
  4. The course of clinical signs of tuberculosis [ Time Frame: Up to 18 months ]
  5. The course of X-Ray investigation of lungs [ Time Frame: up to 18 months ]
  6. The incidence and severity of Adverse Events (AE), Serious Adverse Events (SAE) and drug related adverse events (ADR) [ Time Frame: up to 18 months ]
  7. The course of thyroid hormones [ Time Frame: Up to 18 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:

    • MDR Tuberculosis confirmed by any method in a sputum sample obtained at screening .
    • resistance to isoniazid and rifampicin as demonstrated by drug susceptibility testing (BK+)
    • preservation of sensitivity to fluoroquinolones and aminoglycoside/capreomycin
  • Subjects fo all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol
  • Willing to freely und voluntarily provide informed consent in agreement with sec. 8 of ICH E6 (ICH E6, 2002)
  • Willing and capable to comply with all requirements of the protocol

Exclusion Criteria:

  • Pregnancy or breast-feeding;
  • Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
  • Patients with severe mental disorders;
  • Patients with 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;
  • The use of TB treatment for more than two months before the start of the study;
  • Non-adherence to the DOTS+ therapy;
  • Serious side and/or adverse effects;
  • Decision of a subject to terminate his/her participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607449


Contacts
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Contact: Marina V Lankina, PhD rhisha06@rambler.ru
Contact: Dinara D Zhiyenbayeva, M. P. H. zhiyenbayeva777@gmail.com

Locations
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Kyrgyzstan
National Center of Phthisiatry Recruiting
Bishkek, Kyrgyzstan
Contact: Abdulaat S Kadyrov, MD    +996312570925    abdylat.kadyrov@gmail.com   
Contact: Atyrkul Toktogonova, Cond. Med. Sc.    +996312570925    atyrkul7@gmail.com   
Sponsors and Collaborators
Scientific Center for Anti-infectious Drugs, Kazakhstan
National Center of Phthisiatry, Bishkek, Kyrgyzstan
Ministry of Health, Kazakhstan
Almaty City Tuberculosis Dispensary, Almaty, Kazakhstan
Regional Anti-TB Dispensary of Karagandy Oblast, Kazakhstan
Karaganda State Medical University, Karaganda, Kazakhstan
Investigators
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Study Director: Amirkan A Azembayev, Cond.Phar.Sc. JSC "Scientific Center for Anti-infectious Drugs"

Additional Information:
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Responsible Party: Scientific Center for Anti-infectious Drugs, Kazakhstan
ClinicalTrials.gov Identifier: NCT02607449     History of Changes
Other Study ID Numbers: TP-004 V 3.0
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Scientific Center for Anti-infectious Drugs, Kazakhstan:
MDR TB
Tuberculosis

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections