PK/PD of Caspofungin in Children Severe Infection

Recruiting

• Conditions: Infection, Fungal; Pharmacokinetics
• Interventions: Drug: Caspofungin

• Registration Number: NCT04961593
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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.

Detailed Description

The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.

Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.

The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.

Blood sampling time points of caspofungin are listed as follow:

Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.

The concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-14
• Study Start: 2022-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children receiving caspofungin in pediatric intensive care unit

Exclusion Criteria

• No Informed Consent signed Participate in other clinical trials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	Caspofungin	Children treated with caspofungin in the pediatric intensive care unit

Primary Outcome Measures

Name	Time	Method
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter	Day 1-5	Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

Secondary Outcome Measures

Name	Time	Method
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter	Day1-5	Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter	Day1-5	Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter	Day1-5	Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter	Day 1-5	Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China