CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Rifampicin in higher dosesdrug
Likely dose
Rifampicin in higher doses 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00760149
NCT00760149Phase 2Completed
CompareCT.gov

Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania.

Radboud University Medical Center·interventional·Posted Sep 26, 2008·Updated Sep 9, 2013

In Brief

A Phase 2 clinical trial evaluating Rifampicin in higher doses for Tuberculosis. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesTanzania
CollaboratorsEuropean and Developing Countries Clinical Trials Partnership (EDCTP), Sanofi, Kilimanjaro Christian Medical Centre, Tanzania, Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania, University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands, National Institute for Public Health and the Environment (RIVM)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2008
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.8 years ago

Interventions

Rifampicin in higher dosesdrug

Rifampicin 900 mg (study arm 2), and rifampicin 1200 mg (study arm 3)