NCT05775692

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

March 8, 2023

Last Update Submit

March 8, 2023

Conditions

FluconazoleInfectionNewbornPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • maximum concentration (Cmax)

    Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.

    up to 4 weeks

Study Arms (1)

Newborns and children with the usage of fluconazole

Newborn with fluconazole against infectious diseases.

Drug: fluconazole

Interventions

fluconazoleDRUG

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

Newborns and children with the usage of fluconazole

Eligibility Criteria

Age1 Minute - 28 Days
Sexall(Gender-based eligibility)
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Neonates on fluconazole

You may qualify if:

  • Newborn （0-28d） with fluconazole against infectious diseases. The anti-infective therapy includes drugs commonly used in children infectious diseases.
  • Newborns infectious diseases include pneumonia, sepsis, purulent meningitis and other diseases with infection.
  • Informed consent signed by the parents and/or guardians.

You may not qualify if:

  • Allergic to any class of antibiotics;
  • Receiving other experimental drugs;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Children's Hospital of Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Related Publications (3)

  • Zhao W, Lopez E, Biran V, Durrmeyer X, Fakhoury M, Jacqz-Aigrain E. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013 Jun;98(6):449-53. doi: 10.1136/archdischild-2012-302765. Epub 2012 Dec 19.

    PMID: 23254142BACKGROUND

  • Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E; French Society of Neonatology. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015 Apr;100(4):394-8. doi: 10.1136/archdischild-2014-306873. Epub 2015 Jan 27.

    PMID: 25628457BACKGROUND

  • Jacqz-Aigrain E, Leroux S, Zhao W, van den Anker JN, Sharland M. How to use vancomycin optimally in neonates: remaining questions. Expert Rev Clin Pharmacol. 2015;8(5):635-48. doi: 10.1586/17512433.2015.1060124. Epub 2015 Aug 4.

    PMID: 26289222BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and plasma

MeSH Terms

Conditions

Infections

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • A-Dong Shen, Master

    Beijing Children's Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

A-Dong Shen, Master

CONTACT

+86-010-59616898shenad16@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of China National Clinical Research Center for Respiratory Diseases

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

January 1, 2020

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)