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NCT03643497

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

Status unknown Last updated 23 August 2018
What this trial tests

trial testing anti-infective drugs in Children;Infection in 800 participants. Status unknown.

Timeline
1 July 2018
Primary endpoint
30 September 2021
31 December 2021

Quick facts

Lead sponsorBeijing Children's Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment800
Start date1 July 2018
Primary completion30 September 2021
Estimated completion31 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Children's Hospital

Who can join

Adults 1 Day to 18, any sex, with Children;Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reappraisal of the Optimal Dose of Meropenem in Critically Ill Infants and Children: a Developmental Pharmacokinetic-Pharmacodynamic Analysis.
    Wang ZM, Chen XY, Bi J, Wang MY, et al · · 2020 · cited 21× · PMID 32513801 · DOI 10.1128/aac.00760-20
  2. Improving the efficacy for meropenem therapy requires a high probability of target attainment in critically ill infants and children.
    Wang Z, Bi J, You D, Tang Y, et al · · 2022 · cited 2× · PMID 36278190 · DOI 10.3389/fphar.2022.961863

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