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drugset / Trial / NCT04437836

Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic

NCT04437836 ↗

Phase 1/2 Completed 31 enrolled Kilimanjaro Clinical Research Institute European and Developing Countries Clinical Trials Partnership (EDCTP) · collab
Non-randomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2019-07-01
Primary completion
2022-06-30
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifampin Small molecule 30 mg/kg —
Subject Rifampin Small molecule 40 mg/kg —

Indications

No indication recorded.