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Population Pharmacokinetics of Anti-infective Drugs in Children With Infectious Diseases

NCT03113344 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2017-12-19

No results posted yet for this study

Summary

This study is based on the hypothesis that the pharmacokinetics of anti-infective drugs in children are different from adults. We aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious diseases. In this study, we 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, we also want to correlate use of anti-infective 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 infectious diseases in children. It will also set the foundation for further studies to improve anti-infective drug therapies for children.

Conditions

  • Children; Infection

Interventions

DRUG

cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs

According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.

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
2017-06-21
Primary Completion
2025-10-01
Completion
2025-12-31

Countries

  • China

Study Locations

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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 NCT03113344 on ClinicalTrials.gov