PK/PD of Caspofungin in Children Severe Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caspofungin.
- Who it may be relevant to
- Registry conditions: Pharmacokinetics, Infection, Fungal. Basic parameters: 3 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
Overview
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.
Interventions
- 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.
Primary outcome measures
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [Time frame: Day 1-5]
Secondary outcome measures (4)
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter [Time frame: Day 1-5]
- AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter [Time frame: Day1-5]
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter [Time frame: Day1-5]
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter [Time frame: Day1-5]
Eligibility criteria
Inclusion criteria
- Children receiving caspofungin in pediatric intensive care unit
Exclusion criteria
- No Informed Consent signed Participate in other clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 2 centers
- Children's Hospital of Fudan University — Shanghai
- Children's Hospital of Fudan University — Shanghai
Publications
- 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
Identifiers
NCT: NCT04961593 · fdpicu-24