PK/PD of Caspofungin in Children Severe Infection

Официальное название

Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [Срок оценки: Day 1-5]

Вторичные конечные точки (4)

• Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter [Срок оценки: Day 1-5]
• AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter [Срок оценки: Day1-5]
• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter [Срок оценки: Day1-5]
• Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter [Срок оценки: Day1-5]

Критерии участия

Критерии включения

• Children receiving caspofungin in pediatric intensive care unit

Критерии исключения

• No Informed Consent signed Participate in other clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Китай · 2 центра

• Children's Hospital of Fudan University — Шанхай
• Children's Hospital of Fudan University — Шанхай

Публикации

• 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

Идентификаторы

NCT: NCT04961593 · fdpicu-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗