NCT03625739Recruiting
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis
Source: ClinicalTrials.gov · Last updated 15 Aug 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 8 Aug 2018
- Start date
- 1 Jul 2018
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Beijing Children's Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT03625739
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Jul 2018 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Parents and/or guardians do not agree to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 1 day to 18 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital of Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.