Understanding how anti-tuberculosis drugs work in children
Official title: Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
Run by Beijing Children's Hospital · NCT03625739 · Data updated 2026-11-12
This study is trying to see how children's bodies process anti-tuberculosis drugs differently than adults to improve treatment for kids with tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 18 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Beijing Children's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | July 1, 2018 |
| Main results expected | October 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 15, 2018 |
| Trial ID | NCT03625739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 0-18 years who are undergoing anti-tuberculosis therapy.
✕Probably not a fit
Patients who are not receiving anti-tuberculosis drugs or have allergies to these medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the pharmacokinetics of anti-tuberculosis drugs in children, hypothesizing that their drug metabolism differs from that of adults. Researchers will collect plasma samples from 100 children undergoing treatment for tuberculosis and analyze these samples using high-performance liquid chromatography. They will develop population pharmacokinetic models to assess drug concentrations and correlate these with treatment effectiveness and adverse effects. The findings are expected to enhance treatment strategies for tuberculosis in pediatric patients.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer individualized treatment regimens for children with tuberculosis.
How similar studies have gone: Other studies have shown success in pharmacokinetic modeling for adult populations, but this approach in children is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Beijing Children's Hospital of Capital Medical University
Beijing, China Recruiting
Study contacts
- Principal investigator: A-Dong Shen, Master — Beijing Children's Hospital of Capital Medical University
- Study coordinator: A-Dong Shen, Master
- Email: shenad16@hotmail.com
- Phone: +86-010-59616898
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.