Invasive Fungal Infections
Conditions
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).
Interventions
DRUGCaspogunfin
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).
Sponsors
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
China
Outcome results
None listed