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Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

Recruitingn/aAges 1 Day - 18 YearsAllBeijing Children's Hospital
NCT03625739 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • anti-tuberculosis drug
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Where

1 site
Beijing Children's Hospital of Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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