PK/PD of Caspofungin in Children Severe Infection

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961593
• Other study ID #: fdpicu-24
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Children's Hospital of Fudan University
• Contact: Yixue Wang, doctor
• Phone: 8613524669352
• Email: yixuewang08[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• Children receiving caspofungin in pediatric intensive care unit

Exclusion Criteria:

• No Informed Consent signed Participate in other clinical trials

Related Conditions & MeSH terms

• Communicable Diseases
• Infection, Fungal
• Infections
• Mycoses
• Pharmacokinetics

Intervention

Drug:
• Caspofungin
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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1-5
Secondary	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	Day 1-5
Secondary	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.	Day1-5
Secondary	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.	Day1-5
Secondary	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.	Day1-5