A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis

NCT02057289 | Terminated Phase 1

• 1 other identifier: 2013-4868
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the pharmacokinetics (the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body) of micafungin when it is given at 5mg/kg dose to immunocompromised children as anti-fungal prophylaxis. These children are at high risk for developing invasive fungal disease due to their compromised immunity and associated variable degree and duration of neutropenia. Currently, children who receive micafungin are given daily or alternate day dosing. The investigators will give a ONE TIME dose of micafungin and draw PK levels up to 96 hours post-infusion. The investigators goal is to obtain comparable micafungin drug concentrations at the end of 96 hours (4 days) as compared to lower dose at every 24 hour dosing. The investigators dosing proposal is likely to be effective prophylaxis for immunocompromised patients and would broaden its applicability to larger populations.

Conditions

Immunocompromised; Bone Marrow Transplant; Cancer

Keywords

pediatric; antifungal; bone marrow; AML or relapsed ALL

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics to measure the levels of micafungin

  Blood samples from the above time points will be analyzed to study the bodily absorption, distribution, metabolism, and excretion of micafungin

  Prior to the micafungin infusion at hour 0, at the end of the infusion (60 min), then at 11/2, 2, 4, 6, 8, 10, 24, 36, 48, 60, 72, 84 and 96 hours after the start of the micafungin infusion.

Study Arms (1)

Micafungin

EXPERIMENTAL

Subjects will be administered 5 mg/kg of micafungin intravenously as a ONE TIME dose. For patients undergoing Hematopoietic Stem Cell Transplant (HSCT), Micafungin will be given on during rest days (i.e. days when no chemotherapy is administered) and blood for pharmacokinetic measurements will be drawn over next 96 hours. Following this, further anti-fungal coverage will be at the discretion of the patient's attending physician. (I.e. other antifungal agent(s) or Micafungin at a standard clinical dose; repeat doses of 5mg/kg will NOT be administered.)

Drug: Micafungin

Interventions

Micafungin DRUG

Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma. It inhibits the production of beta-1,3-glucan, an essential component of fungal cell walls. Micafungin is administered intravenously. It received final approval from the U.S. Food and Drug Administration on March 16, 2005, and gained approval in the European Union on April 25, 2008.

Also known as: Mycamine

Micafungin

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who are at risk for fungal infection and require prophylaxis. Example: patients undergoing blood and marrow transplant, immunodeficiency patients, patients with aplastic anemia.
• Age \>= 6 months to \<= 10 years (at time of enrollment).
• Patients with adequate organ function (documented within 2 weeks prior to start of micafungin):
• Creatinine \< 2 times upper limit normal
• Total bilirubin and AST \< 3 times upper limit normal

You may not qualify if:

• 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. This is due to the fact that during transplant, Fluconazole is usually switched to agents with better coverage. This will avoid the possibility of reducing effective antifungal coverage for the purpose of the study.
• Failure to sign informed consent, or inability to undergo informed consent process.
• It is not medically advisable to obtain the specimens necessary for this study.

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

Neoplasms; Leukemia, Myeloid, Acute

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Parinda Mehta, MD

  CCHMC

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

US (1)