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PK/PD of Caspofungin in Children Severe Infection

ConditionsPharmacokineticsInfection, Fungal
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorChildren's Hospital of Fudan University

About this trial

Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children receiving caspofungin in pediatric intensive care unit

Disqualifiers

No Informed Consent signed Participate in other clinical trials

Trial population

Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Caspofungin

    Drug

    For children 3 months of age, the recommended dose is 70 mg/m2 for load and then 50 mg/m2 for maintenance, intravenous injection, once daily up to 5 days.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Treatment group1 intervention

Trial outcomes

Primary outcomes

1

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

Time frame
Day 1-5

Secondary outcomes

1

Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug

Time frame
Day 1-5
2

AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter

Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.

Time frame
Day1-5
3

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter

Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.

Time frame
Day1-5
4

Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter

Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.

Time frame
Day1-5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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