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Search / Trial NCT01802502

Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation

Launched by UNIVERSITAS PADJADJARAN · Feb 28, 2013

Trial Information

Current as of May 11, 2025

Completed

Keywords

Tuberculous Meningitis Rifampicin Bioequivalence Oral Administration Intravenous Administration

ClinConnect Summary

Introduction:

In a recent clinical trial the investigators have shown that a higher dose of rifampicin administered intravenously (600 mg iv) during the first 2 weeks of treatment is safe and associated with a survival benefit in adults with TB meningitis. An oral (rather than iv) dose would help implementation of intensified treatment for TB meningitis. However, it is hard to predict what oral dose of rifampicin will result in rifampicin exposures similar to 600 mg iv, due to differences in bio-availability (oral vs. iv) and the unpredictable dose-concentration relationship (nonlinear pha...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 years or older
  • Probable/possible tuberculosis meningitis using uniform case definition
  • Agree to participate in the study
  • Exclusion Criteria:
  • Patient with antituberculosis treatment within last 2 weeks.
  • Increase liver function \>5x upper limit of normal
  • Pregnancy

About Universitas Padjadjaran

Universitas Padjadjaran, a prestigious academic institution in Indonesia, is dedicated to advancing medical research and clinical trials that contribute to the improvement of healthcare outcomes. With a strong emphasis on interdisciplinary collaboration and innovation, the university harnesses its extensive resources and expertise to conduct rigorous studies aimed at addressing pressing health challenges. Through its commitment to ethical research practices and community engagement, Universitas Padjadjaran plays a pivotal role in fostering evidence-based medicine and enhancing the quality of life for diverse populations.

Locations

Bandung, West Java, Indonesia

Patients applied

0 patients applied

Trial Officials

Rovina Ruslami, M.D., PhD

Principal Investigator

Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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