Understanding how anti-tuberculosis drugs work in children
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
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 |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Beijing Children's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT03625739 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 0-18 years who are undergoing anti-tuberculosis therapy.
Not a fit: Patients who are not receiving anti-tuberculosis drugs or have allergies to these medications may not benefit from this study.
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 performed: Other studies have shown success in pharmacokinetic modeling for adult populations, but this approach in children is relatively novel.
Eligibility criteria
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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.