Alternate Day Micafungin: A PK Study in Pediatric Patients

Alternate Day Micafungin Anti-Fungal Prophylaxis in Immunocompromised Pediatric Patients: A Pharmacokinetic Study

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).

Study Overview

• Status: Completed
• Conditions: Fungal Infection
• Intervention / Treatment: Drug: Micafungin

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Micafungin; 3 mg/kg given once	Drug: Micafungin; 3 mg/kg IV once over 1 hour; Other Names: MYCAMINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.	48 hours

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 11, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (Estimate): February 12, 2009

Study Record Updates

• Last Update Posted (Estimate): February 16, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Prophylaxis; Pharmacokinetic; Immunocompromised; Anti-fungal
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: Micafungin PK