Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

• Sponsor: Shandong University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05881109
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Drug: Caspogunfin

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Mar 3, 2019
• Actual Study Completion Date: Mar 3, 2019

Outcome Measures

Primary Outcome Measures

1. 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) .

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wuhan Children's Hospital	Wuhan		China

Sponsors and Collaborators

• Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Zhao, professor, Shandong University
• ClinicalTrials.gov Identifier: NCT05881109
• Other Study ID Numbers: caspofungin-001
• First Posted: May 31, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Mycoses; Invasive Fungal Infections

Study Results

No Results Posted as of May 31, 2023