Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

Completed

• Conditions: Invasive Fungal Infections

• Registration Number: NCT05881109
• Lead Sponsor: Shandong University

Brief Summary

Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-03-03
• Study Completion: 2019-03-03
• Status Verified: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-28
• Last Update Submitted: 2023-05-28
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The adolescents (12 - 17 years) underwent allo-HSCT
• Use caspofungin for the prevention or treatment of fungal infections

Exclusion Criteria

• Intolerable to caspofungin
• Participate into other clinical studies
• There are conditions that researchers do not consider it appropriate to join the research.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis	1 day	The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) .
The PTAs of trough concentration	the trough concentration (24 hours after administration) at the steady state	PTA of patients with CAS trough concentration ≥ 1 μg/mL
The PTAs of AUC24/MIC for various species of Candida spp isolates	1 day	The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L

Trial Locations

Locations (1)

Wuhan Children's Hospital; 🇨🇳 Wuhan, China