Alternate Day Micafungin: A PK Study in Pediatric Patients

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842504
• Other study ID #: Micafungin PK
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2009
• Last updated: February 15, 2012
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• Micafungin
3 mg/kg IV once over 1 hour

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.		48 hours	No