MedTrace Logo

Population Pharmacokinetics of Meropenem and Linezolid in Children With Severe Infectious Diseases

NCT03643497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2018-08-23

No results posted yet for this study

Summary

This study is based on the hypothesis that the pharmacokinetics of meropenem and linezolid in severe infectious children are different from mild infectious children and adults. The investigators aim to study the population pharmacokinetics of children receiving the meropenem and linezolid for treatment of severe infectious diseases. In this study, the investigators will detect drug concentration in plasma and cerebrospinal fluid by using residual blood samples of blood and cerebrospinal fluid gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, the investigators also want to correlate use of meropenem and linezolid with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of severe infectious diseases in children. It will also set the foundation for further studies to improve anti- infective drug therapies for severe infectious children.

Conditions

  • Children；Infection

Interventions

DRUG

anti-infective 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

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

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

  • Zhao Wei, 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
2021-09-30
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT03643497 on ClinicalTrials.gov