PK/PD of Caspofungin in Children Severe Infection

NCT04961593 | Recruiting

• 1 other identifier: fdpicu-24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pharmacokinetics; Infection, Fungal

Outcome Measures

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

  Day 1-5

Secondary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

  Day 1-5

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

  Day1-5

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

  Day1-5

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

  Day1-5

Study Arms (1)

Treatment group

Children treated with caspofungin in the pediatric intensive care unit

Drug: Caspofungin

Interventions

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 group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Children receiving caspofungin in pediatric intensive care unit

You may not qualify if:

• No Informed Consent signed Participate in other clinical trials

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (1)

• Xu N, Shi Y, Ju G, Liu X, Yan G, Zheng Y, Hou S, Xiang X, Lu G, Ouyang D, Zhu X, Wang Y. Population pharmacokinetics of caspofungin in critically ill Chinese children: a prospective observational study. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0127725. doi: 10.1128/aac.01277-25. Epub 2025 Dec 30.

  PMID: 41468548 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Mycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Guoping Lu, doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yixue Wang, doctor

CONTACT

8613524669352; yixuewang08@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)