Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

Invasive Fungal Infections Clinical Trial

Official title:

Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881109
• Other study ID #: caspofungin-001
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 3, 2019

Study information

• Verified date: May 2023
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 3, 2019
• Est. primary completion date: March 3, 2019
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Caspogunfin
No specific interventions were administrated. Participants receive interventions as part of routine medical care, where CAS was infused intravenously over 60 min at a loading dose of 70 mg/m2 on day 1, followed by a maintenance dose of 50 mg/m2 (maximum: 70 mg daily).

Locations

Country	Name	City	State
China	Wuhan Children's Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis	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) .	1 day
Primary	The PTAs of AUC24/MIC for various species of Candida spp isolates	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	1 day
Primary	The PTAs of trough concentration	PTA of patients with CAS trough concentration = 1 µg/mL	the trough concentration (24 hours after administration) at the steady state