Anidulafungin PK in Infants and Toddlers

Invasive Fungal Infections Clinical Trial

Official title:

Anidulafungin PK in Infants and Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734500
• Other study ID #: Pro00000637
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2008
• Last updated: November 16, 2012
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Anidulafungin
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Michael Cohen-Wolkowiez

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Yes