Alternate Day Micafungin: A PK Study in Pediatric Patients - Full Text View

Sponsor:	Children's Hospital Medical Center, Cincinnati
Collaborator:	Astellas Pharma Inc
Information provided by:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00842504

Purpose

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).

Condition	Intervention	Phase
Fungal Infection	Drug: Micafungin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: FK 463 Micafungin

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Micafungin 3 mg/kg given once	Drug: Micafungin 3 mg/kg IV once over 1 hour Other Name: MYCAMINE

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

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842504

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Astellas Pharma Inc

Investigators

Principal Investigator:

Parinda Mehta, MD

Children's Hospital Medical Center, Cincinnati

More Information

No publications provided

Responsible Party:	Parinda Mehta, M.D., Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier:	NCT00842504 History of Changes
Other Study ID Numbers:	Micafungin PK
Study First Received:	February 11, 2009
Last Updated:	August 4, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Anti-fungal
Immunocompromised
Pharmacokinetic
Prophylaxis
Pharmacokinetics

Additional relevant MeSH terms:

Mycoses
Antifungal Agents
Micafungin

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012