Alternate Day Micafungin: A PK Study in Pediatric Patients
Information source: Children's Hospital Medical Center, Cincinnati
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infection
Intervention: Micafungin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s):
Parinda Mehta, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Overall contact:
Parinda Mehta, MD, Phone: (513)636-5917, Email: Parinda.Mehta@cchmc.org
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).
Clinical Details
Official title: Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study
Study design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.
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 toxicity. Also, breakthrough infections have been reported
with the use of some of the oral agents due to poor oral absorption. An alternative approach
is the use of intravenous micafungin for fungal prophylaxis. Micafungin has a distinct
advantage due to its better safety profile, specifically in terms of liver and kidney
toxicity. Currently, children who receive micafungin are given daily dosing. This study
will examine the pharmacokinetics of micafungin when it is given on an every other day
schedule. It will examine whether every other day micafungin will provide drug exposure
equivalent to daily dosing while reducing administration costs and improving patient
convenience. Both animal and adult human data support the use of this approach. Fifteen
patients will be enrolled on this study and will be given a single dose of micafungin (3
mg/kg). Blood samples will be drawn for pharmacokinetic measurements after administration of
micafungin.
Eligibility
Minimum age: N/A.
Maximum age: 10 Years.
Gender(s): Both.
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.
Locations and Contacts
Parinda Mehta, MD, Phone: (513)636-5917, Email: Parinda.Mehta@cchmc.org
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Parinda Mehta, MD, Phone: 513-636-5917, Email: Parinda.Mehta@cchmc.org
Stephanie L Edwards, RN, Phone: (513)636-9292, Email: StephanieL.Edwards@cchmc.org
Parinda Mehta, MD, Principal Investigator
Additional Information
Starting date: July 2007
Ending date: December 2009
Last updated: February 11, 2009
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