Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Tuberculosis in children is a major public health problem and it contributes 10% of the total
TB cases worldwide. TB treatment outcomes in children are challenged by insufficient
consideration of the relationships between doses administered, concentrations achieved and
eventual desirable and undesirable effects (pharmacodynamics) of TB drugs. Rifampicin is a
pivotal TB drug and data from adults suggest that a much higher dose of rifampicin (35 mg/kg
instead of 10 mg/kg), resulting in much higher rifampicin exposures in plasma, is safe and
tolerable and may provide a higher efficacy. The dose needed in children to achieve the same
exposure in plasma is unknown.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Kilimanjaro Clinical Research Institute
Collaborators:
EDCTP European and Developing Countries Clinical Trials Partnership (EDCTP)