Alternate Day Micafungin: A PK Study in Pediatric Patients

NCT00842504 | Completed Phase 1

• 1 other identifier: Micafungin PK
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fungal Infection

Keywords

Anti-fungal; Immunocompromised; Pharmacokinetic; Prophylaxis; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Every other day micafungin will provide drug exposure equivalent to daily dosing while reducing administration costs and improving patient convenience.

  48 hours

Study Arms (1)

Micafungin

OTHER

3 mg/kg given once

Drug: Micafungin

Interventions

Micafungin DRUG

3 mg/kg IV once over 1 hour

Also known as: MYCAMINE

Micafungin

Eligibility Criteria

• Age: 29 Days - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Mycoses

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Parinda Mehta, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

US (1)