Clinical trials: Pretomanid
Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis
PRACTECAL-PKPD Sub Study
PRACTECAL-PKPD is an exploratory pharmacokinetic and pharmacodynamic sub-study investigating the relationship between the patients' exposure to anti- tuberculosis (TB) drugs in the TB-PRACTECAL trial investigational regimens and…
- Conditions
- Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis
- Trial name
- PRACTECAL-PKPD (NCT04081077)
- Testing
- Bedaquiline, Pretomanid, Moxifloxacin
- Where
- 5 sites in Belarus, South Africa
- Volunteers
- 240 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Tuberculosis
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- NCT03338621
- Testing
- Pretomanid, Bedaquiline, Moxifloxacin
- Where
- 26 sites in Brazil, Georgia and 6 more
- Volunteers
- 455 people
- Sponsor
- Global Alliance for TB Drug Development
Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM)
A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis
The treatment of rifampicin-resistant/multidrug-resistant pulmonary tuberculosis (RR-TB) is characterized by a long treatment course, a high incidence of adverse reactions, a low cure rate, and a high recurrence rate.
- Conditions
- Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM), Pretomanid
- Trial name
- NCT07191834
- Volunteers
- 60 people
- Sponsor
- Wuhan Pulmonary Hospital
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB
Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India
Existing problem with DR TB management: Injectable regimens for longer duration with toxicity Poor adherence, treatment failures, continued transmission Need of the study: Oral regimens of shorter duration Improved treatment…
- Conditions
- Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB, Non-responsive Multidrug-Resistant Pulmonary TB
- Trial name
- mBPaL (NCT05040126)
- Testing
- Linezolid, Bedaquiline, Pretomanid
- Where
- India
- Volunteers
- 400 people
- Sponsor
- Tuberculosis Research Centre, India
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, Pulmonary, Tuberculosis, Multidrug-Resistant
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR
- Trial name
- PRISM-TB (NCT06441006)
- Testing
- Bedaquiline, Linezolid, Pretomanid
- Where
- 6 sites in Mongolia, Pakistan and 3 more
- Volunteers
- 400 people
- Sponsor
- University of California, San Francisco
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
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects (CL-009)
This will be a Phase 1, single-center, randomized, balanced, single-dose, two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the pharmacokinetics of PA-824.
- Trial name
- CL-009 (NCT01830439)
- Testing
- PA-824 200mg, PA-824 50mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Efficacy and Safety
A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis
Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate.
- Trial name
- BPaLM (NCT07126639)
- Testing
- bedaquiline, Pretomanid (Pa), linezolid
- Volunteers
- 200 people
- Sponsor
- Wuhan Pulmonary Hospital
Pulmonary TB, Pulmonary Tuberculosis
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult…
- Conditions
- Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis
- Trial name
- NCT06058299
- Testing
- sorfequiline, Pretomanid, Linezolid
- Where
- 22 sites in Georgia, Philippines and 3 more
- Volunteers
- 309 people
- Sponsor
- Global Alliance for TB Drug Development
Pulmonary Tuberculosis
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00567840
- Testing
- PA-824
- Where
- 2 sites in South Africa
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Rifampicin Resistant Tuberculosis
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with…
- Trial name
- NCT05586230
- Testing
- Pretomanid, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB)
- Where
- 5 sites in Brazil, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus…
- Trial name
- NC-003 (NCT01691534)
- Testing
- TMC207 (J), PA-824 (PA), pyrazinamide (Z)
- Where
- 2 sites in South Africa
- Volunteers
- 105 people
- Sponsor
- Global Alliance for TB Drug Development
Drug Susceptible Pulmonary Tuberculosis
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
- Trial name
- NCT07525427
- Testing
- Bedaquiline, pretomanid and TBD09, Bedaquiline, pretomanid and linezolid
- Where
- 13 sites in South Africa
- Volunteers
- 150 people
- Sponsor
- Gates Medical Research Institute
Renal Impairment, Tuberculosis
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including…
- Trial name
- NCT03896750
- Testing
- PA-824
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pulmonary Tuberculosis
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive…
- Trial name
- NCT00944021
- Testing
- PA-824, Rifafour e-275 mg
- Volunteers
- 69 people
- Sponsor
- Global Alliance for TB Drug Development
Multi-drug Resistant Tuberculosis
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
- Trial name
- NCT04309656
- Testing
- Pretomanid
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
To evaluate the efficacy, safety and tolerability of various doses and durations of linezolid plus bedaquiline and pretomanid after 26 weeks of treatment in participants with either pulmonary XDR-TB, pre-XDR-TB, or treatment…
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis
- Trial name
- ZeNix (NCT03086486)
- Testing
- Pretomanid, Linezolid, Bedaquiline
- Where
- 11 sites in Georgia, Moldova and 2 more
- Volunteers
- 181 people
- Sponsor
- Global Alliance for TB Drug Development