Research Papers

This database includes peer-reviewed publications authored by TB Alliance staff. Use the tags on the left to filter by subject, or search for a particular author or term using the search bar.

Tag: Clinical Trial Results

Displaying 29 papers

Bedaquiline-pretomanid-moxifloxacin-pyrazinamide for drug-sensitive and drug-resistant pulmonary tuberculosis treatment: a phase 2c, open-label, multicentre, partially randomised controlled trial

Publication: Lancet Infectious Diseases

Author(s): Muge Cevik, MD Lindsay C Thompson, MPhil Caryn Upton, MD Valéria Cavalcanti Rolla Mookho Malahleha, MD Blandina Mmbaga, PhD Nosipho Ngubane, MD Zamzurina Abu Bakar, MD Mohammed Rassool, MD Ebrahim Variava, MD Rodney Dawson, MD Suzanne Staples, DPhil Umes

5/2024

Tags: Clinical Development, Clinical Trial Results, Global Pipeline, MDR-TB, Moxifloxacin, Pretomanid/PA-824, Pyrazinamide

Bedaquiline–Pretomanid–Linezolid Regimens for Drug-Resistant Tuberculosis

Publication: New England Journal of Medicine

Author(s): Francesca Conradie, et al., for the ZeNix Trial Team

9/2022

Tags: Bedaquiline (TMC-207), BPaL, Clinical Trial Results, Linezolid, MDR-TB, Pretomanid/PA-824, XDR-TB

A partially randomised trial of pretomanid, moxifloxacin and pyrazinamide for pulmonary TB

Publication: International Journal of Tuberculosis and Lung Disease

Author(s): C. D. Tweed, G. H. Wills, A. M. Crook

3/2021

Tags: Clinical Trial Results, Moxifloxacin, Pretomanid/PA-824, Pyrazinamide, STAND/NC-006

Phase 1 Study of the Effects of the Investigational Tuberculosis Treatment Pretomanid, Alone and in Combination with Moxifloxacin, on the QTc Interval in Healthy Volunteers

Author(s): Mengchun Li , George A Saviolakis , Wael El-Amin , Mamodikoe K Makhene , Blaire Osborn , Jerry Nedelman , Tian J Yang , Daniel Everitt

12/2020

Tags: Clinical Trial Results, Moxifloxacin, Pretomanid/PA-824

Treatment of Highly Drug-Resistant Pulmonary Tuberculosis

Publication: The New England Journal of Medicine

Author(s): Francesca Conradie, M.B., B.Ch., Andreas H. Diacon, M.D., Nosipho Ngubane, M.B., B.Ch., Pauline Howell, M.B., B.Ch., Daniel Everitt, M.D., Angela M. Crook, Ph.D., Carl M. Mendel, M.D., Erica Egizi, M.P.H., et al., for the Nix-TB Trial Team*

3/2020

Tags: Bedaquiline (TMC-207), BPaL, Clinical Trial Results, Linezolid, MDR-TB, Pretomanid/PA-824, Regimen Change, Trial Design, XDR-TB

Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial

Publication: The Lancet Respiratory Medicine

Author(s): Conor D Tweed, Rodney Dawson, Divan A Burger, Almari Conradie, Angela M Crook, Carl M Mendel, Francesca Conradie, Andreas H Diacon, Nyanda E Ntinginya, Daniel E Everitt, Frederick Haraka, Mengchun Li, Christo H van Niekerk, Alphonse Okwera

11/2019

Tags: Bedaquiline (TMC-207), BPaZ, Clinical Trial Results, MDR-TB, Moxifloxacin, NC-005, PaMZ, Pretomanid/PA-824, Trial Design

Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status

Publication: BMC Pulmonary Medicine

Author(s): Conor D. Tweed, Angela M. Crook, Rodney Dawson, Andreas H. Diacon, Timothy D. McHugh, Carl M. Mendel, Sarah K. Meredith, Lerato Mohapi, Michael E. Murphy, Andrew J. Nunn, Patrick P. J. Phillips, Kasha P. Singh, Melvin Spigelman, Stephen H. Gillespie

8/2019

Tags: Clinical Trial Results, ReMoxTB

Toxicity associated with tuberculosis chemotherapy in the REMoxTB study

Publication: BMC Infectious Diseases

Author(s): Tweed, Conor D., Crook, Angela M. Amukoye, Evans I. Dawson, Rodney Diacon, Andreas H. Hanekom, Madeline McHugh, Timothy D. Mendel, Carl M. Meredith, Sarah K. Murphy, Michael E. Murthy, Saraswathi E. Nunn, Andrew, Spigelman, M.

7/2018

Tags: Clinical Trial Results, ReMoxTB

A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens

Publication: BMC Medicine 2017 15:207

Author(s): Patrick P. J. Phillips, Carl M. Mendel, Andrew J. Nunn, Timothy D. McHugh, Angela M. Crook, Robert Hunt, Anna Bateson and Stephen H. Gillespie

12/2017

Tags: Clinical Trial Results, ReMoxTB

Spot sputum samples are at least as good as early morning samples for identifying Mycobacterium tuberculosis

Publication: BMC Medicine 2017 15:207

Author(s): Patrick P. J. Phillips, Carl M. Mendel, Andrew J. Nunn, Timothy D. McHugh, Angela M. Crook, Robert Hunt, Anna Bateson and Stephen H. Gillespie

12/2017

Tags: Clinical Trial Results, ReMoxTB

The impact of HIV and antiretroviral therapy on TB risk in children: A systematic review and meta-analysis

Publication: Thorax Online, 23 Jan. 2017. Web. 31 Jan. 2017.

Author(s): Dodd, P. J., A. J. Prendergast, C. Beecroft, B. Kampmann, and J. A. Seddon. "The Impact of HIV and Antiretroviral Therapy on TB Risk in Children: A Systematic Review and Meta-analysis."

1/2017

Tags: Childhood TB, Clinical Trial Results, TB-HIV

The pharmacokinetics of rifampicin, isoniazid, pyrazinamide and ethambutol in infants dosed at revised WHO-recommended treatment guidelines

Publication: Bekker A, Schaaf HS, Murray S, et. al. The pharmacokinetics of rifampicin, isoniazid, pyrazinamide and ethambutol in infants... Antimicrob Agents Chemother. 2016 Jan 25. pii: AAC.02600-15. doi: 10.1128/aac.02600-15.

1/2016

Tags: Childhood TB, Clinical Trial Results, HRZE, Pharmacokinetics, Pyrazinamide

Bactericidal Activity of Pyrazinamide and Clofazimine Alone and in Combinations with Pretomanid and Bedaquiline

Publication: Diacon AH, Dawson R, von Groote-Bidlingmaier F, et. al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med. 2015 Apr 15;191(8):943-53. doi: 10.1164/rccm.201410-1801OC.

4/2015

Tags: Bedaquiline (TMC-207), BPaZ, Clinical Development, Clinical Trial Results, Clofazamine, NC-003, Pretomanid/PA-824, Pyrazinamide, TB-HIV

Shorter moxifloxacin-based regimens for drug-sensitive tuberculosis

Publication: Alffenaar JW, Gumbo T, Aarnoutse R. Shorter moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2015 Feb 5;372(6):576. doi: 10.1056/NEJMc1414718#SA1.

2/2015

Tags: Clinical Development, Clinical Trial Results, HRZE, Moxifloxacin, ReMoxTB

Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug

Publication: Svensson EM, Murray S, Karlsson MO, Dooley KE. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug. J Antimicrob Chemother. 2015 Apr;70(4):1106-14. doi: 10.1093/jac/dku504.

12/2014

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics, Rifapentine

Evaluation of the Pharmacokinetic Interaction between Repeated Doses of Rifapentine or Rifampin and a Single Dose of Bedaquiline in Healthy Adult Subjects

Publication: Winter H, Egizi E, Erondu N, et. al. Evaluation of the pharmacokinetic interaction between repeated doses of rifapentine or rifampin and a single dose of bedaquiline in healthy adult subjects. Antimicrob Agents Chemother. 2015 Feb;59(2):1219-24. doi: 10.1

12/2014

Tags: Bedaquiline (TMC-207), Clinical Development, Clinical Trial Results, Pharmacokinetics, Rifapentine

Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 withconcomitant lopinavir-ritonavir, efavirenz, or rifampin

Publication: Dooley KE, Luetkemeyer AF, Park JG, et. al. Phase I safety, pharmacokinetics, and pharmacogenetics study of the antituberculosis drug PA-824 with concomitant lopinavir-ritonavir, efavirenz, or rifampin. Antimicrob Agents Chemother. 2014 Sep;58(9):5245-52.

9/2014

Tags: Clinical Development, Clinical Trial Results, Pharmacokinetics, Pretomanid/PA-824, TB-HIV

Four-Month Moxifloxacin-Based Regimens for Drug-Sensitive Tuberculosis

Publication: Gillespie SH, Crook AM, McHugh TD, et. al. Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis. N Engl J Med. 2014 Oct 23;371(17):1577-87. doi: 10.1056/NEJMoa1407426.

4/2014

Tags: Clinical Development, Clinical Trial Results, HRZE, Moxifloxacin, ReMoxTB

Effect of a high-calorie, high-fat meal on the bioavailability and pharmacokinetics of PA-824 in healthy adult subjects

Publication: Winter H, Ginsberg A, Egizi E, et. al. Effect of a High-Calorie, High-Fat Meal on the Bioavailability and Pharmacokinetics of PA-824 in Healthy Adult Subjects. Antimicrob Agents Chemother. 2013 Nov; 57(11): 5516–5520. doi: 10.1128/AAC.00798-13

11/2013

Tags: Clinical Development, Clinical Trial Results, Pharmacodynamics, Pretomanid/PA-824

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