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

Results First Received: August 31, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Invasive Fungal Infections
Intervention:	Drug: Anidulafungin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Anidulafungin	Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)

Participant Flow: Overall Study

	Anidulafungin
STARTED	15
COMPLETED	14
NOT COMPLETED	1

Baseline Characteristics

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Reporting Groups

	Description
Anidulafungin	Intravenous anidulafungin (loading dose, 3 mg/kg once followed by 1.5 mg/kg/day)

Baseline Measures

	Anidulafungin
Number of Participants [units: participants]	15
Age [units: years] Mean ± Standard Deviation	0.22 ± 0.32
Age, Customized [units: participants]
<=24 months	15
Gender [units: participants]
Female	5
Male	10
Region of Enrollment [units: participants]
United States	15

Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

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. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michael Cohen-Wolkowiez
Organization: Duke University
phone: 9196688812
e-mail: michael.cohenwolkowiez@duke.edu

No publications provided

Responsible Party:	Michael Cohen-Wolkowiez, 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

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