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Population Pharmacokinetics of Fluconazole in the Treatment of Neonatal Fungal Infectious Disease

NCT05775692 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-03-20

No results posted yet for this study

Summary

This study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. We aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. In this study, we will detect fluconazole 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 fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. It will also set the foundation for further studies to improve fluconazole therapies for newborns and children.

Conditions

  • Fluconazole
  • Infection
  • Newborn
  • Pharmacokinetics

Interventions

DRUG

fluconazole

According to the models of population pharmacokinetics,the investigators and want to correlate use of fluconazole with treatment effectiveness and safety in newborns

Sponsors & Collaborators

  • Shandong University

    collaborator OTHER

  • Beijing Children's Hospital

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
1 Minute
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-10-31
Completion
2023-12-31

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 NCT05775692 on ClinicalTrials.gov