CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Anidulafungin +1 moredrug
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/NCT00761267
NCT00761267Phase 3Completed
CompareCT.gov

A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

Pfizer·interventional·Posted Sep 29, 2008·Updated Apr 4, 2019

In Brief

A Phase 3 clinical trial evaluating Anidulafungin and Fluconazole for Candidemia. Completed, enrolled 70 participants across 45 sites in 10 countries.

Detailed Summary

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidemia
CountriesBrazil, Canada, Greece, Italy, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2008
Enrollment StartFeb 1, 2009
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 17.8 years ago

Interventions

Anidulafungindrug

Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days.

Fluconazoledrug

Subjects may be switched to oral fluconazole \[6-12 mg/kg/day (not to exceed 800mg/day\] provided they meet specified criteria. Maximum total treatment duration is 49 days.