Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
In this phase II clinical trial, the pharmacokinetics, safety and (short-term) efficacy of
higher than standard doses rifampicin will be studied during the intensive phase of
tuberculosis (TB) treatment. Patients enrolled in this study will either get the standard TB
regimen (including 600 mg rifampicin; first study arm), or 900 mg rifampicin plus isoniazid,
ethambutol and pyrazinamide in standard dosages (second study arm), or 1200 mg rifampicin
plus the other drugs in standard dosages (third study arm). All patients will get the
standard TB regimen during the continuation phase of treatment.
Phase:
Phase 2
Details
Lead Sponsor:
Radboud University
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania Kilimanjaro Christian Medical Centre, Tanzania National Institute for Public Health and the Environment (RIVM) Sanofi University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands