pretomanid (PA-824) Trials

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

pretomanid (PA-824) / Global Alliance for TB Drug Development

ZeNix, NCT03086486: Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Completed

181

RoW

Pretomanid, PA-824, Pa, Linezolid, L, Lin, Zyvox, Bedaquiline, TMC-207, B, Sirturo, Placebo Linezolid

Global Alliance for TB Drug Development

Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pre-XDR-TB, XDR-TB

02/21

02/22

NCT05040126: Modified BPaL Regimen for Managing Pre-XDR TB and MDR (TI/NR) TB in India

Active, not recruiting

400

RoW

Linezolid, Bedaquiline, Pretomanid

Tuberculosis Research Centre, India, International Union Against Tuberculosis and Lung Diseases, Sarvodaya Charitable Trust Hospital, Ghatkopar, Mumbai, Shatabdi Centenary Hospital, Govandi, Mumbai, King George's Medical College and Hospital, Lucknow, SN Medical College, Agra, Govt Medical College & Hospital, Bhavnagar, Govt. Medical College & Hospital, Surat, National Institute for Tuberculosis and Respiratory Diseases, New Delhi, Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, Delhi, Govt.Rajaji Medical college and hospital, Madurai

Pre-Extensively Drug-Resistant Pulmonary TB, Treatment Intolerant Multidrug-Resistant Pulmonary TB, Non-responsive Multidrug-Resistant Pulmonary TB

12/24

PRISM-TB, NCT06441006: Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

Not yet recruiting

690

RoW

Bedaquiline, Sirturo, Linezolid, Zyvox, Pretomanid, Pretamyl, Moxifloxacin, Avelox, Control Arm FQ-S MDR/RR-TB regimen, designed according to latest WHO guidelines

University of California, San Francisco, Johns Hopkins University

Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR

06/29

11/29

PRACTECAL-EE, NCT04207112: Economic Evaluation of New MDR TB Regimens

Completed

2/3

RoW

Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Standard Drugs

Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Ministry of Health, Republic of Uzbekistan, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd

Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculoses

08/22

TB-PRACTECAL, NCT02589782: Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed

2/3

552

RoW

Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, Linezolid, Zyvox, Clofazimine, Lamprene, Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.

Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Rutgers, The State University of New Jersey, University of California, San Francisco

Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Tuberculosis, Pulmonary

08/22

PRACTECAL-PKPD, NCT04081077: Sub Study

Active, not recruiting

2/3

240

RoW

Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene

Medecins Sans Frontieres, Netherlands, London School of Hygiene and Tropical Medicine, Global Alliance for TB Drug Development, University College, London, Drugs for Neglected Diseases, Swiss Tropical & Public Health Institute, eResearch Technology, Inc., Ministry of Health, Republic of Uzbekistan, World Health Organization, Ministry of Public Health, Republic of Belarus, THINK TB & HIV Investigative Network, University of Liverpool, Wits Health Consortium (Pty) Ltd, Hackensack Meridian Health, University of California, San Francisco, Minsk Republican Research and Practical Centre for Pulmonology and Tuberculosis

Multi-drug Resistant Tuberculosis, Extensively Drug-Resistant Tuberculosis, Pulmonary Tuberculosis

09/22

PRACTECAL-PRO, NCT03942354: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed

2/3

137

RoW

Bedaquiline, Sirturo, R207910, TMC207, Pretomanid, PA-824, Moxifloxacin, Avelox, BAY 12-8039, Linezolid, Zyvox, Clofazimine, Lamprene, Directly observed therapy (DOT)

Medecins Sans Frontieres, Netherlands, University of Sussex, London School of Hygiene and Tropical Medicine, THINK TB & HIV Investigative Network, Wits Health Consortium (Pty) Ltd, Ministry of Public Health, Republic of Belarus, Ministry of Health, Republic of Uzbekistan

Multidrug Resistant Tuberculosis

05/22

panTB-HM, NCT05686356: A Pan-TB Regimen Targeting Host and Microbe

Recruiting

2/3

352

RoW

Sutezolid, N-acetyl cysteine, NAC, Pretomanid, Bedaquiline, Rifafour

The Aurum Institute NPC, Ludwig-Maximilians - University of Munich, Stichting Katholieke Universiteit, Wits Health Consortium (Pty) Ltd, Instituto Nacional de Saúde, Mozambique, National Institute for Medical Research, Tanzania, University of Stellenbosch, Sequella, Inc., Global Alliance for TB Drug Development

Tuberculosis

09/25

PaSEM, NCT04179500: A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers

Completed

RoW

Pretomanid, Pa-824, Bedaquiline, moxifloxacin, pyrazinamide

Global Alliance for TB Drug Development

Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis

06/23

07/24

RAD-TB, NCT06192160: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Not yet recruiting

315

RoW

Isoniazid, INH, Rifampicin, RIF, Pyrazinamide, PZA, Ethambutol, EMB, Bedaquiline, BDQ, Pretomanid, Pa, Linezolid, LZD, TBI-223, Sutezolid, SZD

National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance

Pulmonary Tuberculosis

06/25

04/26

NCT06058299: Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Active, not recruiting

309

RoW

TBAJ-876, Pretomanid, PA-824, Dovprela, Linezolid, Zyvox, Bedaquiline, Sirturo, TMC207, HRZE, HR

Global Alliance for TB Drug Development

Pulmonary TB, Pulmonary Tuberculosis, Drug Sensitive Tuberculosis

01/25

06/26

PARADIGM4TB, NCT06114628: Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

Recruiting

2500

RoW

GSK3036656, BTZ-043, Bedaquiline (B), Delamanid (D), Pretomanid (Pa), Moxifloxacin (M), Linezolid (L), Pyrazinamide (Z), Rifampicin (R), Isoniazid (H), Ethambutol (E)

University College, London, Radboud University Medical Center, London School of Hygiene and Tropical Medicine, University of Oxford, Research Center Borstel, Lygature, TASK Applied Science, Vita-Salute San Raffaele University, Helmholtz Zentrum Munchen, KNCV Tuberculosis Foundation, Critical Path Institute, European Lung Foundation, Instituto de Saude Publica da Universidade do Porto, University of Liverpool, Institut de Recherche Pour le Developpment, University of Hamburg-Eppendorf, University of California, San Francisco, TB Alliance, Find, University of Milano, University of St Andrews, Uppsala University, European Respiratory Society, Tuberculosis Network European Trialsgroup, Janssen, LP, Otsuka Pharmaceutical Development & Commercialization, Inc., German Center for Infection Research, LMU University Hospital Munich, University of Cambridge, GlaxoSmithKline

Pulmonary Tuberculosis

02/27

08/27

NCT05971602: Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Active, not recruiting

514

RoW

Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS), Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS), Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE), Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS), Isoniazid and Rifampicin (HR)

Bill & Melinda Gates Medical Research Institute, Global Alliance for TB Drug Development, Janssen Pharmaceutica, Otsuka Pharmaceutical Co., Ltd.

Pulmonary Tuberculosis

01/25

A Single Center, Randomized, Open Study on Pharmacokinetic Characteristics and Food Effect ( PA-824-1X02 ), ChiCTR2200066301: Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerance and Food Effect of Pretomanid (PA-824) Tablets in Chinese Healthy Subjects

Recruiting

8 subjects in group 1 take a single dose of 200mg under fasted state on Day1 and 200mg after a high-fat meal on Day10; 8 subjects in group 2 take a single dose of 200mg after a high-fat meal on Day1 and 200mg under fasted state on Day10

Peking University Third Hospital; Shenyang Hongqi Pharmaceutical Co., Ltd, Own funds

Tuberculosis

NCT03896750: Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function

Recruiting

PA-824

National Institute of Allergy and Infectious Diseases (NIAID)

Renal Impairment, Tuberculosis

01/25

07/25

NCT02422524: Pretomanid in Adults With Hepatic Impairment

Terminated

PA-824

National Institute of Allergy and Infectious Diseases (NIAID)

Tuberculosis

08/23

11/23

NCT05586230: Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant Tuberculosis

Recruiting

RoW

Pretomanid, Pa, Optimized background regimen (OBR) for multidrug-resistant TB (MDR-TB

National Institute of Allergy and Infectious Diseases (NIAID), Global Alliance for TB Drug Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)

Tuberculosis, Rifampicin Resistant Tuberculosis

01/26

NCT05609552: Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Recruiting

N/A

18F-Pretomanid PET/CT

Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)

Tuberculosis

02/25

02/26



	Diseases Companies Products Productz Mechanisms of Action Sites