NCT00734500

Anidulafungin PK in Infants and Toddlers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Michael Cohen-Wolkowiez · Academic / Other
• Sex: All
• Age: 48 Hours – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Fungal Infections

Interventions

Type	Name	Description
DRUG	Anidulafungin	Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-08-14
• Last updated: 2012-11-21
• Results posted: 2011-12-14

Locations

1 site across 1 country: United States