Anidulafungin PK in Infants and Toddlers

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.

Study Overview

• Status: Completed
• Conditions: Invasive Fungal Infections
• Intervention / Treatment: Drug: Anidulafungin

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Drug: Anidulafungin; Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.; Other Names: Eraxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During and up to 10 days after last dose of study drug.

Collaborators and Investigators

• Sponsor: Michael Cohen-Wolkowiez

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 16, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Anti-Infective Agents; Antifungal Agents; Anidulafungin
• Other Study ID Numbers: Pro00000637