Investigating how caspofungin works in children with severe infections
Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
This study is testing how well the antifungal drug caspofungin works in children with severe infections to see if the current dosing is right for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT04961593 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the pharmacokinetics and pharmacodynamics of caspofungin, an antifungal medication, in children suffering from severe infections with specific conditions such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis. The study will involve blood sampling at various time points after administration to analyze how the drug is metabolized in these unique patient populations. The goal is to determine whether the current dosing recommendations are effective in achieving optimal drug levels in these children.
Who should consider this trial
Good fit: Ideal candidates for this study are children in pediatric intensive care units who are receiving caspofungin.
Not a fit: Patients who are not receiving caspofungin or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for caspofungin in children with severe infections, improving treatment outcomes.
How similar studies have performed: While there is limited data on the pharmacokinetics of caspofungin in this specific population, similar studies have shown the importance of tailored dosing in pediatric patients with complex health conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children receiving caspofungin in pediatric intensive care unit Exclusion Criteria: * No Informed Consent signed Participate in other clinical trials
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guoping Lu, doctor — Children's Hospital of Fudan University
- Study coordinator: Yixue Wang, doctor
- Email: yixuewang08@aliyun.com
- Phone: 8613524669352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.