Anidulafungin PK in Infants and Toddlers

Michael Cohen-Wolkowiez

Status and phase

Completed

Phase 1

Conditions

Invasive Fungal Infections

Treatments

Drug: Anidulafungin

Study type

Interventional

Funder types

Other

Identifiers

NCT00734500

Pro00000637

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

48 hours to 24 months old

Volunteers

No Healthy Volunteers

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.