Status:
COMPLETED
Alternate Day Micafungin: A PK Study in Pediatric Patients
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Fungal Infection
Eligibility:
All Genders
29-10 years
Phase:
PHASE1
Brief 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 exp...
Detailed Description
Disseminated fungal infection is a major cause of morbidity and mortality in immunocompromised children. Many of the drugs used for fungal prophylaxis have been associated with kidney and liver toxici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00842504
Start Date
July 1 2007
End Date
December 1 2009
Last Update
February 16 2012
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229