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Studies how tuberculosis drugs move through children's bodies

Observes how anti-tuberculosis drugs behave in children with tuberculosis, using leftover blood samples.

Plain-language title generated from the registry record
Registry title: Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

Key facts

Where
Beijing, ChinaSee the site

Where in China

  • Beijing Children's Hospital of Capital Medical UniversityBeijing, ChinaTaking people

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Trial details

Who runs it
Beijing Children's Hospital
Trial code
NCT03625739
Record updated
15 August 2018
Original description
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.Read full original descriptionShow less

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.

Inclusion: Children (0-18 years old) with anti-tuberculosis therapy against TB; The anti-tuberculsis therapy includes drugs commonly used in children infectious diseases; Informed consent signed by the parents and/or guardians.

Exclusion: Anti-tuberculosis drugs aren't involved in the therapies of children; It is unable to provide complete medical records or the current condition cannot accept the study process; Patients are allergic to anti-tuberculsis drugs; Parents and/or guardians do not agree to participate in this study.

ClinicalTrials.gov NCT03625739