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Anidulafungin PK in Infants and Toddlers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734500
First Posted: August 14, 2008
Last Update Posted: November 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anidulafungin PK in Infants and Toddlers

Resource links provided by NLM:


Further study details as provided by Michael Cohen-Wolkowiez, Duke University Medical Center:

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 ]
    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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734500


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

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
First Submitted: August 13, 2008
First Posted: August 14, 2008
Results First Submitted: August 31, 2011
Results First Posted: December 14, 2011
Last Update Posted: November 21, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents