Back to resultsAlternate Day Micafungin: A PK Study in Pediatric Patients
Primary Purpose
Fungal Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Micafungin
Sponsored by
About this trial
This is an interventional basic science trial for Fungal Infection focused on measuring Anti-fungal, Immunocompromised, Pharmacokinetic, Prophylaxis, Pharmacokinetics
Eligibility 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.
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Micafungin
Arm Description
3 mg/kg given once
Outcomes
Primary Outcome Measures
Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.
Secondary Outcome Measures
Full Information
NCT ID
NCT00842504
First Posted
February 11, 2009
Last Updated
February 15, 2012
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00842504
Brief Title
Alternate Day Micafungin: A PK Study in Pediatric Patients
Official Title
Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
Keywords
Anti-fungal, Immunocompromised, Pharmacokinetic, Prophylaxis, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micafungin
Arm Type
Other
Arm Description
3 mg/kg given once
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
MYCAMINE
Intervention Description
3 mg/kg IV once over 1 hour
Primary Outcome Measure Information:
Title
Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parinda Mehta, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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Alternate Day Micafungin: A PK Study in Pediatric Patients
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