MedTrace Logo

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

NCT01802502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-06-17

No results posted yet for this study

Summary

Tuberculous (TB) meningitis is the most severe manifestation of TB infection, leaving up to 50% of patients dead or neurologically disabled. Current treatment is similar to treatment of lung TB, although penetration of some antibiotics into the brain is poor and the immune-pathology of TB meningitis is very different from pulmonary TB. In a recent phase II clinical trial from the investigators group, the first of its kind globally, intensified antibiotic treatment, with moxifloxacin and high dose rifampicin, strongly reduced mortality of TB meningitis.

The investigators aim to examine the effect of intensified antibiotic treatment on mortality and morbidity of TB meningitis in a phase 3 clinical trial, preceded with an explorative pharmacokinetic (PK) study to examine if higher oral doses rifampicin result in exposures similar to the i.v. dose used in our phase 2 trial, since oral rifampicin could be implemented much easier in low-resource settings.

Conditions

  • Tuberculous Meningitis

Interventions

DRUG

Rifampicin intravenous

DRUG

Oral rifampicin

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Rovina Ruslami, M.D., PhD · Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin Hospital Bandung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2014-04-30

Countries

  • Indonesia

Study Locations

More Related Trials

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 NCT01802502 on ClinicalTrials.gov