pretomanid (PA-824) / Global Alliance for TB Drug Development  >>  Phase 3
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11 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
pretomanid (PA-824) / Global Alliance for TB Drug Development
STAND, NCT02342886: Shortening Treatment by Advancing Novel Drugs

Completed
3
284
RoW
Moxifloxacin, BAY 12-8039, Avelox, Avalon, Avelon, PA-824, Pyrazinamide, HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination), Rifafour e-275, HR (rifampicin plus isoniazid combination tablets)
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
01/18
05/18
Nix-TB, NCT02333799: A Phase 3 Study Assessing Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis

Completed
3
109
RoW
Bedaquiline, B, TMC-207, PA-824, Pa, pretomanid, Linezolid, L, Lin
Global Alliance for TB Drug Development
Pulmonary Tuberculosis
01/19
08/20
ZeNix, NCT03086486: Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis

Completed
3
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
3
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
12/24
PRISM-TB, NCT06441006: Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis

Not yet recruiting
3
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
NCT03338621: Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

Completed
2/3
455
RoW
Pretomanid, PA-824, Pa, Bedaquiline, B, TMC207, Moxifloxacin, M, Pyrazinamide, Z, HRZE, isoniazid, rifampicin, ethambutol, HR
Global Alliance for TB Drug Development
Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
07/21
06/22
PRACTECAL-EE, NCT04207112: Economic Evaluation of New MDR TB Regimens

Completed
2/3
73
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
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
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
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
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
09/25

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