FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis
NCT02607449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344
Last updated 2022-05-24
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).
Conditions
- Tuberculosis, MDR
Interventions
- DRUG
-
FS-1
FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.
- DRUG
-
Placebo without any active pharmaceutical ingredients
Sponsors & Collaborators
-
Phthisiopulmonology Center of Almaty, Kazakhstan
collaborator UNKNOWN -
National Scientific Center of Phthisiopulmonology, Kazakhstan
collaborator UNKNOWN -
Karaganda Medical University
collaborator OTHER -
West Kazakhstan Marat Ospanov Medical University, Aktobe, Kazakhstan
collaborator UNKNOWN -
Semey State Medical University
collaborator OTHER -
National Center of Phthisiatry, Bishkek, Kyrgyzstan
collaborator OTHER -
Invivo laboratory, Kazakhstan
collaborator UNKNOWN -
Scientific Center for Anti-infectious Drugs, Kazakhstan
lead INDUSTRY
Principal Investigators
-
Amirkan A Azembayev, Cond.Phar.Sc. · JSC "Scientific Center for Anti-infectious Drugs"
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2020-08-31
- Completion
- 2020-10-31
Countries
- Kazakhstan
- Kyrgyzstan
Study Locations
More Related Trials
-
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
NCT06674291 ·Status: NOT_YET_RECRUITING
-
The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB
NCT02409290 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
NCT05278988 ·Status: COMPLETED ·Phase: PHASE4
-
Metronidazole for Pulmonary Tuberculosis (South Korea)
NCT00425113 ·Status: COMPLETED ·Phase: PHASE2
-
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
NCT02501421 ·Status: COMPLETED ·Phase: PHASE1
-
Tuberculosis (TB) Immunotherapy Phase 2 Study
NCT01380119 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
NCT01364324 ·Status: COMPLETED
-
Pilot Clinical Trial of PRS TB Regimen I - Phase II
NCT03561753 ·Status: COMPLETED ·Phase: PHASE4
-
A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB
NCT06526039 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
NCT05746611 ·Status: COMPLETED ·Phase: PHASE4
-
Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
NCT02901288 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants
NCT04472897 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy and Safety of Intravenous Treatment of Tuberculosis
NCT04150367 ·Status: TERMINATED
-
PanACEA - STEP2C -01
NCT05807399 ·Status: RECRUITING ·Phase: PHASE2
-
New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
NCT04397536 ·Status: UNKNOWN
-
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
NCT05081401 ·Status: RECRUITING ·Phase: PHASE3
-
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
NCT03665402 ·Status: COMPLETED ·Phase: NA
-
A New Treatment for Primary Smear-positive Pulmonary Tuberculosis With Interleukin-2
NCT04766307 ·Status: UNKNOWN ·Phase: PHASE4
-
Multi-Drug Resistant Tuberculosis in Korea
NCT00341601 ·Status: COMPLETED
-
Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
NCT00760149 ·Status: COMPLETED ·Phase: PHASE2
-
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
NCT03862248 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis
NCT07126639 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Drug Concentrations in the Treatment of MDR-TB Related to Minimum Inhibitory Concentrations
NCT02816931 ·Status: COMPLETED
-
Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China
NCT04421495 ·Status: UNKNOWN ·Phase: PHASE4
-
Improving the Management of Drug Resistant Tuberculosis in the UK
NCT02875574 ·Status: COMPLETED