An observational study in Pharmacokinetics and Infection, Fungal, sponsored by Children's Hospital of Fudan University. Recruiting at 2 sites in China. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Children's Hospital of Fudan University · Observational
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.
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.
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 60 is below the median of 153 across 85 observational studies indexed under Mycoses.
Browse Mycoses studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
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Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children treated with caspofungin in the pediatric intensive care unit
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.
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
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
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
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
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
Plan to share: No
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