- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057289
A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis (Micafungin)
Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are at risk for fungal infection and require prophylaxis. Example: patients undergoing blood and marrow transplant, immunodeficiency patients, patients with aplastic anemia.
- Age >= 6 months to <= 10 years (at time of enrollment).
Patients with adequate organ function (documented within 2 weeks prior to start of micafungin):
- Creatinine < 2 times upper limit normal
- Total bilirubin and AST < 3 times upper limit normal
Exclusion Criteria:
- 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. This is due to the fact that during transplant, Fluconazole is usually switched to agents with better coverage. This will avoid the possibility of reducing effective antifungal coverage for the purpose of the study.
- Failure to sign informed consent, or inability to undergo informed consent process.
- It is not medically advisable to obtain the specimens necessary for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micafungin
Subjects will be administered 5 mg/kg of micafungin intravenously as a ONE TIME dose. For patients undergoing Hematopoietic Stem Cell Transplant (HSCT), Micafungin will be given on during rest days (i.e. days when no chemotherapy is administered) and blood for pharmacokinetic measurements will be drawn over next 96 hours. Following this, further anti-fungal coverage will be at the discretion of the patient's attending physician. (I.e. other antifungal agent(s) or Micafungin at a standard clinical dose; repeat doses of 5mg/kg will NOT be administered.) |
Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma.
It inhibits the production of beta-1,3-glucan, an essential component of fungal cell walls.
Micafungin is administered intravenously.
It received final approval from the U.S. Food and Drug Administration on March 16, 2005, and gained approval in the European Union on April 25, 2008.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics to measure the levels of micafungin
Time Frame: Prior to the micafungin infusion at hour 0, at the end of the infusion (60 min), then at 11/2, 2, 4, 6, 8, 10, 24, 36, 48, 60, 72, 84 and 96 hours after the start of the micafungin infusion.
|
Blood samples from the above time points will be analyzed to study the bodily absorption, distribution, metabolism, and excretion of micafungin
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Prior to the micafungin infusion at hour 0, at the end of the infusion (60 min), then at 11/2, 2, 4, 6, 8, 10, 24, 36, 48, 60, 72, 84 and 96 hours after the start of the micafungin infusion.
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-4868
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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