Safety, Tolerability, Extended Early Bactericidal Activity and PK of Higher Doses Rifampicin in Adults With Pulmonary TB (HR1)

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ClinicalTrials.gov Identifier: NCT01392911

Recruitment Status : Completed

First Posted : July 13, 2011

Last Update Posted : November 26, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

European and Developing Countries Clinical Trials Partnership (EDCTP)

Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.

University Centre for Chronic Diseases Dekkerswald, Groesbeek, NL

Information provided by (Responsible Party):

Radboud University Medical Center

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	July 2018
Actual Study Completion Date :	November 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Te Brake LHM, de Jager V, Narunsky K, Vanker N, Svensson EM, Phillips PPJ, Gillespie SH, Heinrich N, Hoelscher M, Dawson R, Diacon AH, Aarnoutse RE, Boeree MJ; PanACEA Consortium. Increased bactericidal activity but dose-limiting intolerability at 50 mg.kg-1 rifampicin. Eur Respir J. 2021 Jul 8;58(1):2000955. doi: 10.1183/13993003.00955-2020. Print 2021 Jul.

Svensson RJ, Svensson EM, Aarnoutse RE, Diacon AH, Dawson R, Gillespie SH, Moodley M, Boeree MJ, Simonsson USH. Greater Early Bactericidal Activity at Higher Rifampicin Doses Revealed by Modeling and Clinical Trial Simulations. J Infect Dis. 2018 Aug 14;218(6):991-999. doi: 10.1093/infdis/jiy242.

Boeree MJ, Diacon AH, Dawson R, Narunsky K, du Bois J, Venter A, Phillips PP, Gillespie SH, McHugh TD, Hoelscher M, Heinrich N, Rehal S, van Soolingen D, van Ingen J, Magis-Escurra C, Burger D, Plemper van Balen G, Aarnoutse RE; PanACEA Consortium. A dose-ranging trial to optimize the dose of rifampin in the treatment of tuberculosis. Am J Respir Crit Care Med. 2015 May 1;191(9):1058-65. doi: 10.1164/rccm.201407-1264OC.

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