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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspogunfin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The adolescents (12 - 17 years old) undergoing allo-HSCT and receiving CAS as prevention or treatment for IFIs
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Children's Hospital | Wuhan | China |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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