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Anidulafungin PK in Infants and Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00734500
First received: August 13, 2008
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.


Condition Intervention Phase
Invasive Fungal Infections
 Drug: Anidulafungin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anidulafungin PK in Infants and Toddlers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Area under the curve at steady state


Secondary Outcome Measures:
  • Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. [ Time Frame: During and up to 10 days after last dose of study drug. ] [ Designated as safety issue: Yes ]
    Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.


Enrollment: 15
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment
 Drug: Anidulafungin
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Other Name: Eraxis

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 24 months at the time of enrollment
  • Patient must have sufficient venous access to permit administration of study medication
  • Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
  • Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

  • Patients with a history of anaphylaxis attributed to an echinocandin
  • Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
  • Previous participation in this study
  • Previous exposure to an echinocandin in the month prior to study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734500

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Michael Cohen-Wolkowiez
  More Information

No publications provided

Responsible Party: Michael Cohen-Wolkowiez, Assistant Professor, Department of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00734500     History of Changes
Other Study ID Numbers: Pro00000637
Study First Received: August 13, 2008
Results First Received: August 31, 2011
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Mycoses
Anidulafungin
Echinocandins
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013