PK of First-Line Drugs in Children <5kg

Background:

The current standard TB treatment is Isoniazid + Rifampin + Pyrazinamide + Ethambutol (HRZE). This treatment is used to treat both adults and children, however appropriate doses of child-friendly formulations of these drugs simply do not exist in today's market. Those treating children with TB are forced to adapt adult treatments, often by crushing or cutting pills, in order to treat children. This approach institutionalizes poor outcomes and the development of drug resistance. Newborn and infants weighing 5 kg or less have not been adequately studied either as single drug entities or in combination (including as FDCs). Therefore, the proper dosages for these children is not even fully known.

TB Alliance is working to develop child-appropriate formulations of the current standard TB treatment to improve the treatment of pediatric TB patients, in line with WHO's recommendations, and streamline the development of child appropriate forms of new TB drugs currently in development for adults. In this particular program, TB Alliance is working understand the pharmacokinetics of current first-line TB drugs in children 5 kg or less, which will inform developers and policymakers as to the proper way to treat newborn and infant TB patients

Phase 1

Trial Components

Regimens