Back to resultsAnidulafungin PK in Infants and Toddlers
Primary Purpose
Invasive Fungal Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anidulafungin
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Fungal Infections
Eligibility 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.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Treatment
Outcomes
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.
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.
Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.
Full Information
NCT ID
NCT00734500
First Posted
August 13, 2008
Last Updated
November 16, 2012
Sponsor
Michael Cohen-Wolkowiez
1. Study Identification
Unique Protocol Identification Number
NCT00734500
Brief Title
Anidulafungin PK in Infants and Toddlers
Official Title
Anidulafungin PK in Infants and Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Cohen-Wolkowiez
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Other Intervention Name(s)
Eraxis
Intervention Description
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Primary Outcome Measure Information:
Title
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Description
Area under the curve at steady state
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Description
Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.
Time Frame
During and up to 10 days after last dose of study drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Hours
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Anidulafungin PK in Infants and Toddlers
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