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Pharmacokinetics and Pharmacodynamics of High Versus Standard Dose Rifampicin in Patients With Pulmonary Tuberculosis

NCT00760149 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-09-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rifampicin in higher doses

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

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Sanofi

    collaborator INDUSTRY

  • Kilimanjaro Christian Medical Centre, Tanzania

    collaborator OTHER

  • Kibong'oto National Tuberculosis Hospital, Sanya Juu, Tanzania

    collaborator UNKNOWN

  • University Centre for Chronic Diseases Dekkerswald, Groesbeek, The Netherlands

    collaborator UNKNOWN

  • National Institute for Public Health and the Environment (RIVM)

    collaborator OTHER_GOV

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Rob Aarnoutse, Pharm-D, PhD · Radboud University Medical Center

  • Gibson Kibiki, MD, MMed, PhD · Kilimanjaro Christian Medical Centre,Moshi,Tanzania

  • Martin Boeree, MD PhD · Radboud University Nijmegen Medical Center/UCCZ Dekkerswald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Tanzania

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760149 on ClinicalTrials.gov