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Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

NCT03625739 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2018-08-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

anti-tuberculosis drug

The intervention drugs are prescribed by treating caregiver

Sponsors & Collaborators

  • Shandong University

    collaborator OTHER

  • Hopital Universitaire Robert-Debre

    collaborator OTHER

  • Rennes University Hospital

    collaborator OTHER

  • Beijing Children's Hospital

    lead OTHER

Principal Investigators

  • A-Dong Shen, Master · Beijing Children's Hospital of Capital Medical University

  • Yu-Jie Qi, Master · Beijing Children's Hospital of Capital Medical University

  • Wei Zhao, Doctor · Children's Hospital of Hebei Province;Shandong Provincial Qianfoshan Hospital

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2026-10-01
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625739 on ClinicalTrials.gov