Neutropenic immunosuppressed
Conditions
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient is 3 to 24 months of age with one or more of the following conditions: 1) leukemia, lymphoma, or other cancers 2) bone marrow or peripheral stem transplantation 3) high dose chemotherapy incurring prolonged neutropenia 4) aplastic anemia • Patient has an absolute neutrophil count 38.0°C (oral or tympanic calibrated to oral) within 72 hours of screening. Are the trial subjects under 18? yes Number of subjects for this age range: 9 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient is 24 months (2 years) of age (at time of drug administration). • Patient has proven or probable invasive fungal infection at the time of Enrollment • Patient is taking systemic antifungal therapy with the exception of prophylactic fluconazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare caspofungin plasma concentration profiles and pharmacokinetic parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 50 mg/m2/day (maximum of 70 mg/day) IV, to historical data from adult patients administered caspofungin at a daily 50-mg IV dose. ;Secondary Objective: (1) To compare caspofungin plasma concentration profiles and pharmacokinetics parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 70 mg/m2/day (maximum of 70 mg/day) IV, to historical data from adult patients administered caspofungin at a daily 70-mg IV dose. (2) To evaluate the safety and tolerability of caspofungin administered as daily 50- and 70-mg/m2 IV doses in young children between the ages of 3 and 24 months. ;Primary end point(s): To evaluate and compare caspofungin plasma concentration profiles and pharmacokinetic parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 50 mg/m2/day;Timepoint(s) of evaluation of this end point: 4 – 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare caspofungin plasma concentration profiles and pharmacokinetics parameters (AUC0-24 hr, C1 hr, and C24 hr) obtained from 3- to 24-month-old children administered caspofungin, at 70 mg/m2/day;Timepoint(s) of evaluation of this end point: 4 – 28 days | — |
Countries
United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck & Co., Inc.
Outcome results
None listed