Anidulafungin PK in Infants and Toddlers

Phase 1

Completed

• Conditions: Invasive Fungal Infections
• Interventions: Drug: Anidulafungin

• Registration Number: NCT00734500
• Lead Sponsor: Michael Cohen-Wolkowiez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-08-31
• Results First Submitted QC: 2011-11-09
• Results First Posted: 2011-12-14
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Anidulafungin	Treatment

Primary Outcome Measures

Name	Time	Method
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.	5 days	Area under the curve at steady state

Secondary Outcome Measures

Name	Time	Method
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.	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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States