Clinical trial Recruiting at 1 site Observational Ages 1 Day to 18

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 typeObservational
Ages1 Day to 18 Years
SexAll
Enrollment800 (estimated)
SponsorBeijing Children's Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedJuly 1, 2018
Main results expectedOctober 1, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 15, 2018
Trial IDNCT03625739 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.