Alternate Day Micafungin: A PK Study in Pediatric Patients

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Astellas Pharma Inc
• Treatments: Echinocandins; Micafungin

Criteria

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.