NCT05881109

Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: —

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).

Conditions

• Invasive Fungal Infections

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-03-03
• Completion: 2019-03-03
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study