CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Anidulafungindrug
Likely dose
Anidulafungin 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00734500
NCT00734500Phase 1Completed
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Anidulafungin PK in Infants and Toddlers

Michael Cohen-Wolkowiez·interventional·Posted Aug 14, 2008·Updated Nov 21, 2012

In Brief

A Phase 1 clinical trial evaluating Anidulafungin for Invasive Fungal Infections. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Fungal Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.9 years ago

Interventions

Anidulafungindrug

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