Evaluation of Pharmacokinetics and Safety Tolerability of Higher Doses of Rifampic

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kilimanjaro Clinical Research Institute
• Collaborators: EDCTP; European and Developing Countries Clinical Trials Partnership (EDCTP)
• Treatments: Rifampin

Criteria

Inclusion Criteria:

• Children aged 1 to 14 years with newly diagnosed Tuberculosis

Exclusion Criteria:

• Children with elevated liver function

• Children allergic to first line anti-TB drugs