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
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis, MDR||Drug: FS-1 Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Standard DOTS+ treatment regiment with FS-1 drug.
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.
Placebo without any active pharmaceutical ingredients
- 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.]
- The proportion of subjects with relapse of tuberculosis [ Time Frame: up to 12 months ]
- Change of body weight [ Time Frame: up to 18 months ]
- The median time to occurrence of negative sputum cultures (SCC). [ Time Frame: up to 12 months ]
- The course of clinical signs of tuberculosis [ Time Frame: Up to 18 months ]
- The course of X-Ray investigation of lungs [ Time Frame: up to 18 months ]
- The incidence and severity of Adverse Events (AE), Serious Adverse Events (SAE) and drug related adverse events (ADR) [ Time Frame: up to 18 months ]
- The course of thyroid hormones [ Time Frame: Up to 18 months ]
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
|Contact: Marina V Lankina, PhDfirstname.lastname@example.org|
|Contact: Dinara D Zhiyenbayeva, M. P. H.||email@example.com|
|National Center of Phthisiatry||Recruiting|
|Contact: Abdulaat S Kadyrov, MD +996312570925 firstname.lastname@example.org|
|Contact: Atyrkul Toktogonova, Cond. Med. Sc. +996312570925 email@example.com|
|Study Director:||Amirkan A Azembayev, Cond.Phar.Sc.||JSC "Scientific Center for Anti-infectious Drugs"|