Fungal Infection
Conditions
Brief summary
This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.
Interventions
(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Patient is 3 to 24 months of age with one or more of the following conditions: * Leukemia, lymphoma, or other cancers * Bone marrow or peripheral stem transplantation * High dose chemotherapy leading to a decrease in white blood cells * Aplastic anemia * Patient has an absolute neutrophil count \<500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever \> 38 degreesC (oral or oral equivalent) within 72 hours of screening.
Exclusion criteria
* Patient is \<3 months or \>24 months of age at the time of study drug administration * Patient has proven or probable invasive fungal infection at the time of enrollment * Patient has certain blood clotting or liver function abnormalities * Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days * Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. | 28 Days |
Outcome results
None listed