Clinical trials: MDR Tuberculosis
Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis
Acetohydroxamic Acid Combined With a Short-Course Regimen for MDR-TB (AHA-PLUS)
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course…
- Conditions
- Multidrug-Resistant Tuberculosis, Rifampicin-resistant Tuberculosis, MDR-TB, RR-TB
- Trial name
- AHA-PLUS (NCT07393438)
- Testing
- Acetohydroxamic Acid
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Tuberculosis
TB Immunotherapy Trial With Heat-killed M. Vaccae
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and…
- Trial name
- imm03 (NCT01977768)
- Testing
- V7
- Where
- 2 sites in Mongolia, Ukraine
- Volunteers
- 152 people
- Sponsor
- Immunitor LLC
Multidrug Resistant Tuberculosis
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life…
- Trial name
- PRACTECAL-PRO (NCT03942354)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 6 sites in Belarus, South Africa and 1 more
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Medecins Sans Frontieres, Netherlands
Pulmonary Tuberculosis
Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid…
- Trial name
- NCT05971602
- Testing
- Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)
- Where
- 13 sites in Philippines, South Africa
- Volunteers
- 93 people
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Multidrug Resistant
Drug Concentrations in the Treatment of MDR-TB Related to Minimum Inhibitory Concentrations
Multi-drug resistant tuberculosis (MDR-TB) is steadily increasing world-wide, urging for the need of improved treatment strategies.
- Trial name
- TDM-MDR-TB (NCT02816931)
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Karolinska Institutet
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
MDR-TB
A Study of Ultrashort PRS Regimen V in the Treatment of MDR-TB
This is an exploratory, prospective, randomized, active control, and open label clinical trial to evaluate the efficacy and safety of 6-9 months treatment with the ultrashort PRS Regimen V.
- Trial name
- NCT05278988
- Testing
- PRS Regimen V, MDR-TB Treatment Regimen(WHO)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
Shortening Treatment by Advancing Novel Drugs
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with…
- Trial name
- STAND (NCT02342886)
- Testing
- Moxifloxacin, PA-824, Pyrazinamide
- Where
- 26 sites in Georgia, Kenya and 6 more
- Volunteers
- 284 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, MDR
Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis
The purpose of this study is to assess the efficacy and safety of 2 repurposed drugs (acetylsalicylic acid and ibuprofen), for use as adjunct therapy added to, and compared with, the standard of care (SoC) WHO-recommended TB…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, MDR, Tuberculosis Infection
- Trial name
- SMA-TB (NCT04575519)
- Testing
- Control group, ASA group, IBU group
- Where
- 3 sites in Georgia, South Africa
- Volunteers
- 426 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
TB Multi-drug Resistant
Epidemiology of MDR-TB in Peru
The purpose of this study is to better understand tuberculosis (TB) and the risk of infection with TB, in Peru. TB is a disease that is caused by bacteria and transmitted through droplets in the air that come from the lungs of an…
- Trial name
- Estudio Epi (NCT00676754)
- Testing
- Statens Serum Institut RT23 2TU tuberculin
- Where
- Peru
- Volunteers
- 18,544 people, healthy volunteers welcome
- Sponsor
- Harvard University Faculty of Medicine
Pulmonary Tuberculosis
The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)
The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary…
- Trial name
- NCT06476210
- Testing
- BDL regimen
- Where
- 7 sites in China
- Volunteers
- 45 people
- Sponsor
- Beijing Chest Hospital
MDR-TB, Tuberculosis Multi Drug Resistant Active
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
The FAST-MDR trial is an externally-controlled, multicentre trial with one prospective arm, evaluating the non-inferiority of the effectiveness of BPaLM in the interventional arm versus the effectiveness of the long, conventional…
- Conditions
- MDR-TB, Tuberculosis Multi Drug Resistant Active, Antibiotic Resistance, Mycobacterium Tuberculosis
- Trial name
- FAST-MDR (NCT07486024)
- Testing
- Bedaquiline Oral Tablet
- Where
- 5 sites in France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis
Line Probe Assay Evaluation Study
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from…
- Conditions
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- YD (NCT02984579)
- Testing
- YD REBA MTB-MDR, Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2
- Volunteers
- 888 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Tuberculosis
Genome Sequencing of Multidrug Resistant Tuberculosis (MDR TB) in Sputum
Drug resistant tuberculosis is a growing problem world wide. The current methods for diagnosis are time consuming and may delay diagnosis and treatment for many weeks.
- Trial name
- MDRTB01 (NCT02245347)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- St George's Healthcare NHS Trust
Multi-drug Resistant Tuberculosis
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant…
- Trial name
- PandrTB (NCT03827811)
- Where
- 7 sites in Kazakhstan, Lesotho and 4 more
- Volunteers
- 625 people
- Sponsor
- University of Cape Town
Multi-drug Resistant Tuberculosis
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
The purpose of this study is to provide safety and efficacy data for TMC207 and to demonstrate that TMC207 added to a background regimen (BR) is superior to treatment with the BR plus placebo.
- Trial name
- NCT01600963
- Testing
- Arm A Double-blind Phase: TMC207, Treatment Failure During Double-blind Phase: TMC207, Treatment Failure During Follow-up Phase: TMC207
- Where
- 44 sites in Brazil, Cambodia and 15 more
- Sponsor
- Janssen Infectious Diseases BVBA
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis
Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- PaSEM (NCT04179500)
- Testing
- Pretomanid, Bedaquiline, moxifloxacin
- Where
- 4 sites in Georgia, South Africa
- Volunteers
- 26 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Thoracic Surgery
Study of TB Lesions Obtained in Therapeutical Surgery
The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential…
- Conditions
- Tuberculosis, Thoracic Surgery, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
- Trial name
- SH-TBL (NCT02715271)
- Testing
- therapeutical surgery for TB
- Where
- Georgia
- Volunteers
- 192 people
- Sponsor
- Fundació Institut Germans Trias i Pujol
Tuberculosis, Pulmonary
MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB. Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.
- Trial name
- NCT00495339
- Testing
- Levofloxacin
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Sanofi
Multidrug Resistant Tuberculosis
Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan
Multidrug resistant tuberculosis (MDR TB) is a growing problem and few people have access to adequate diagnosis and treatment. The current recommended treatment regimen for MDR TB has a minimum of 20 months duration with high…
- Trial name
- NCT02496572
- Testing
- Short course MDR-TB treatment regimen
- Where
- Uzbekistan
- Volunteers
- 110 people
- Sponsor
- Medecins Sans Frontieres, Netherlands