Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anidulafungin PK in Infants and Toddlers

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.
 
ClinicalTrials.gov Identifier: NCT00734500
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : December 14, 2011
Last Update Posted : November 21, 2012
Sponsor:
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Invasive Fungal Infections
Intervention Drug: Anidulafungin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anidulafungin
Hide Arm/Group Description Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Arm/Group Title Anidulafungin
Hide Arm/Group Description Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
0.22  (0.32)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<=24 months Number Analyzed 15 participants
15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Hide Description Area under the curve at steady state
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anidulafungin
Hide Arm/Group Description:
Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: µg*h/mL
84
(30 to 278)
2.Secondary Outcome
Title Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anidulafungin
Hide Arm/Group Description:
Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anidulafungin
Hide Arm/Group Description Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)
All-Cause Mortality
Anidulafungin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Anidulafungin
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Cardiac disorders   
Death [1]  1/15 (6.67%)  1
[1]
Cardiac and respiratory failure - family withdrew care - patient died soon after administration of 1st dose of study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anidulafungin
Affected / at Risk (%) # Events
Total   2/15 (13.33%)    
Gastrointestinal disorders   
Direct hyperbilirubinemia [1]  2/15 (13.33%)  2
[1]
2 subjects experienced direct hyperbilirubinemia possibly related to study drug; study drug was stopped in 1 of these patients. Both patients had history of previous hyperbilirubinemia episodes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Cohen-Wolkowiez
Organization: Duke University
Phone: 9196688812
EMail: michael.cohenwolkowiez@duke.edu
Layout table for additonal information
Responsible Party: Michael Cohen-Wolkowiez, Duke University
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