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Anidulafungin PK in Infants and Toddlers

NCT00734500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-11-21

Study results available
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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

DRUG

Anidulafungin

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

Sponsors & Collaborators

  • Michael Cohen-Wolkowiez

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Hours
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734500 on ClinicalTrials.gov