Alternate Day Micafungin: A PK Study in Pediatric Patients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00842504
First received: February 11, 2009
Last updated: February 15, 2012
Last verified: February 2012
  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 1

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:


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 ]

Enrollment: 15
Study Start Date: July 2007
Study Completion Date: December 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00842504     History of Changes
Other Study ID Numbers: Micafungin PK
Study First Received: February 11, 2009
Last Updated: February 15, 2012
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 July 22, 2014