Fungal Infection Clinical Trial
Official title:
Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study
The purpose of this study is to examine the pharmacokinetics of micafungin when it is given on an every other day schedule. The study will determine if every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples for PK measurements will be obtained for 48 hours following a single dose of micafungin (3 mg/kg).
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 10 Years |
Eligibility |
Inclusion Criteria: - Hospitalized patients who are at risk for fungal infection and require prophylaxis. - Age = 10 years excluding neonates - Children must have an indwelling venous access device - Patients with adequate organ function (documented within 2 weeks prior to start of micafungin): creatinine < 2 times upper limit normal; ALT, AST and total bilirubin = 3 times upper limit normal Exclusion Criteria: - Patients who are < 28 days old (neonates) or > 10 years of age - Patients who have history of past or evidence of active fungal disease (by either radiological studies or biopsy proven) or are being treated for presumed fungal infection. - Patients who have history of allergy to micafungin or other echinocandin preparations, such as Caspofungin or Anidulafungin. - Patients who have received micafungin or other echinocandin preparations in the previous two weeks. - Patients receiving antifungal prophylaxis other than Fluconazole at the time of enrollment. - Failure to sign informed consent, or inability to undergo informed consent process. - Not medically advisable to obtain the specimens necessary. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Astellas Pharma Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. | 48 hours | No |
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