Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

This study is based on the hypothesis that the pharmacokinetics of anti-tuberculosis drugs in TB children are different from adults. The investigators aim to study the population pharmacokinetics of children receiving the anti-tuberculsis drugs for treatment of TB. In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, the investigators also want to correlate use of anti-tuberculsis drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of TB in children. It will also set the foundation for further studies to improve anti-tuberculosis drug therapies for children.

NCT Number	NCT03625739
Lead Sponsor	Beijing Children's Hospital Collaborators: Shandong University, Hopital Universitaire Robert-Debre, Rennes University Hospital
Conditions	Tuberculosis
Enrollment	800 participants
Start Date	2018-07-01
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2018-08-15