Clinical trials: Pretomanid
Tuberculosis
Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam
The purpose of this study is to determine the safety and tolerability of PA-824 when given with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a clinically important degree as measured by the effect…
- Trial name
- NCT01768273
- Testing
- Midazolam, PA-824
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects
This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824.
- Trial name
- CL-003 (NCT01828827)
- Testing
- PA-824 1000 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
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
Pulmonary Tuberculosis
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
- Trial name
- NCT01498419
- Testing
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z)
- Where
- 8 sites in South Africa, Tanzania
- Volunteers
- 207 people
- Sponsor
- Global Alliance for TB Drug Development
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
Economic Evaluation of New MDR TB Regimens
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs.
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses
- Trial name
- PRACTECAL-EE (NCT04207112)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 73 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Dovprela
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must…
- Trial name
- NCT06471088
- Testing
- Dovprela
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Viatris Inc.
Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB…
- Conditions
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- TB-PRACTECAL (NCT02589782)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 7 sites in Belarus, South Africa and 1 more
- Volunteers
- 552 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Drug Susceptible Pulmonary Tuberculosis
Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.
- Trial name
- NCT07517445
- Testing
- Bedaquiline, pretomanid, linezolid, Nicotinamide (NAM)
- Where
- 4 sites in South Africa
- Volunteers
- 165 people
- Sponsor
- Gates Medical Research Institute
Tuberculosis, Pulmonary
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB
The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive…
- Trial name
- NCT07672405
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 12 sites in South Africa, Tanzania
- Volunteers
- 100 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis
Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine…
- Trial name
- NCT05609552
- Testing
- 18F-Pretomanid PET/CT
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Pulmonary Tuberculosis
A Phase 3 Trial Assessing Safety and Efficacy of B-Pa-L in Participants With DR-TB
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of bedaquiline plus PA-824 plus linezolid after 6 months of treatment (option for 9 months for participants who remain culture…
- Trial name
- NCT02333799
- Testing
- Bedaquiline, PA-824, Linezolid
- Where
- 3 sites in South Africa
- Volunteers
- 109 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and…
- Trial name
- NCT01215851
- Testing
- PA-824, Pyrazinamide, TMC207
- Where
- 2 sites in South Africa
- Volunteers
- 85 people
- Sponsor
- Global Alliance for TB Drug Development