Actively Recruiting

Age: 1Day - 18Years
All Genders
NCT03625739

Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

Led by Beijing Children's Hospital · Updated on 2018-08-15

800

Participants Needed

1

Research Sites

443 weeks

Total Duration

On this page

Sponsors

B

Beijing Children's Hospital

Lead Sponsor

S

Shandong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

Who Can Participate

Age: 1Day - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0 to 18 years with tuberculosis receiving anti-tuberculosis therapy
  • Anti-tuberculosis therapy includes drugs commonly used for infectious diseases in children
  • Informed consent signed by parents or guardians
Not Eligible

You will not qualify if you...

  • Children not treated with anti-tuberculosis drugs
  • Unable to provide complete medical records or unable to participate in study procedures
  • Known allergy to anti-tuberculosis drugs
  • Parents or guardians do not consent to participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Children's Hospital of Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

A

A-Dong Shen, Master

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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