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 Development

Displaying 52 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

Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience

Publication: International Journal of Infectious Diseases

Author(s): Francesca Saluzzo, Juan Espinosa-Pereiro, Stephan Dressler, Ezio Tàvora Dos Santos Filho, Stephanie Seidel, Jesus Gonzalez Moreno, Norbert Heinrich, Adrian Sanchez-Montalva, Daniela Maria Cirillo

3/2023

Tags: Advocacy, Clinical Development, Community Engagement, Trial Design, Underserved Populations

Next-Generation Diarylquinolines Improve Sterilizing Activity of Regimens with Pretomanid and the Novel Oxazolidinone TBI-223 in a Mouse Tuberculosis Model

Publication: Antimicrobial Agents and Chemotherapy

Author(s): Si-Yang Li, Paul J. Converse, Fabrice Betoudji, Jin Lee, Khisimuzi Mdluli, Anna Upton, Nader Fotouhi, Eric L. Nuermberger

3/2023

Tags: Bedaquiline (TMC-207), BPaL, Clinical Development, Drug Discovery, Linezolid, Preclinical Data, Preclinical Models, Pretomanid/PA-824

The Clinical Dose of Pretomanid: An Exposure-Response Perspective

Author(s): Jerry R. Nedelman, David H. Salinger, Vishak Subramoney, Rob Woolson, Karen Wade, Mengchun Li, Daniel Everitt, Carl M. Mendel, Mel Spigelman

12/2020

Tags: BPaL, Clinical Development, Nix-TB, Pretomanid/PA-824

Tuberculosis

Publication: Tuberculosis.Nature Reviews Disease Primers. 2016/10/27/online. 16076. Macmillan Publishers Limited. http://dx.doi.org/10.1038/nrdp.2016.76

Author(s): Pai, Madhukar; Behr, Marcel A.; Dowdy, David; Dheda, Keertan; Divangahi, Maziar; Boehme, Catharina C.; Ginsberg, Ann; Swaminathan, Soumya; Spigelman, Melvin; Getahun, Haileyesus; Menzies, Dick; Raviglione, Mario

10/2016

Tags: Clinical Development, Drug Discovery, MDR-TB, TB-HIV

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials

Publication: Journal of Empirical Research on Human Research Ethics 1556264616657452, first published on June 30, 2016 doi:10.1177/1556264616657452

Author(s): Kathleen M. MacQueen, Natalie T. Eley, Mike Frick, Laia Ruiz Mingote, Alicia Chou, Stephanie S. Seidel, Stacey Hannah, and Carol Hamilton

6/2016

Tags: Advocacy, Clinical Development, Community Engagement, TB-HIV, Trial Design

Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials

Publication: Phillips PPJ, Mendel CM, Burger DA, et al. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials. BMC Medicine. 2016 Mar.14:19. doi: 10.1186/s12916-016-0565-y

3/2016

Tags: Biomarkers, Clinical Development, Moxifloxacin, ReMoxTB, Trial Design

Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults

Publication: Furin J., Alirol E, Allen E, et. al. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. Int J Tuberc Lung Dis. 20161 Mar; 20(3): 290-294.

3/2016

Tags: Clinical Development, Editorials, MDR-TB, Trial Design, XDR-TB

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement

Publication: Nachman S, Ahmed A, Amanullah, et. al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis. 2015 Jun;15(6):711-20. doi: 10.1016/S1473-3099(15)00007-9.

5/2015

Tags: Advocacy, Childhood TB, Clinical Development, Editorials, Policy, Trial Design

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

Evaluation of moxifloxacin-containing regimens in pathologically distinct murine tuberculosis models

Publication: Li SY, Irwin SM, Converse PJ, Mdluli KE, Lenaerts AJ, Nuermberger EL. Evaluation of moxifloxacin-containing regimens in pathologically distinct murine tuberculosis models. Antimicrob Agents Chemother. 2015 Jul;59(7):4026-30. doi: 10.1128/AAC.00105-15.

4/2015

Tags: Clinical Development, HRZE, Moxifloxacin, Preclinical Data, Preclinical Models, ReMoxTB

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

The Tuberculosis Drug Discovery and Development Pipeline and Emerging Drug Targets

Publication: Mdluli K, Kaneko T, Upton A. The tuberculosis drug discovery and development pipeline and emerging drug targets.Cold Spring Harb Perspect Med. 2015 Jan 29;5(6). pii: a021154. doi: 10.1101/cshperspect.a021154.

1/2015

Tags: Advocacy, Clinical Development, Drug Discovery, Editorials, Global Pipeline, MDR-TB

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

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

Strengthening neglected tropical disease research through enhancing research-site capacity: an evaluation of a novel web application to facilitate research collaborations

Publication: Furtado T, Franzen S, van Loggerenberg F, et. al. Strengthening neglected tropical disease research through enhancing research-site capacity: an evaluation of a novel web application to facilitate research collaborations. PLoS Negl Trop Dis. 2014 Nov 13;8

11/2014

Tags: Advocacy, Clinical Development, Editorials, Policy

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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