Study of Caspofungin Drug Behavior in Children with Severe Fungal Infection Receiving Treatment in Pediatric Intensive Care

What this Trial Is About

Researchers are studying how the anti-fungal drug caspofungin is processed in children with severe infections, especially those with specific conditions like liver insufficiency, low protein levels, ECMO treatment, or sepsis. The study focuses on understanding the drugs pharmacokinetics and pharmacodynamics PKPD in these children to better understand how these conditions affect the drugs behavior in the body. The study involves children receiving caspofungin in a pediatric intensive care unit. For children older than three months, the recommended dose is 70 mg per square meter as a loading dose followed by 50 mg per square meter daily for maintenance, given through an intravenous injection for up to five days. For newborns and infants younger than three months, a dose of 25 mg per square meter is recommended. Blood samples will be taken before and at several times after drug administration to measure caspofungin concentration. Participants will have blood drawn at specific times before receiving the drug, and then 1, 2, 4, 8, 12, and 24 hours after administration. These samples will help researchers analyze how the drug is absorbed and cleared in children with the targeted conditions. The main outcome measured is the time to reach the highest concentration of the drug in plasma. Secondary outcomes include maximum drug concentration, total drug exposure over time, and how long the drug stays in the body. The study is conducted by the Childrens Hospital of Fudan University and monitors children during their treatment in intensive care.

PK/PD of Caspofungin in Children Severe Infection