CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 85 enrolled
Drug / intervention
Anidulafungindrug
Likely dose
Anidulafungin 200 mgfrom 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/NCT01734525
NCT01734525Phase 4Completed

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

Universidade Federal do Rio de Janeiro·interventional·Posted Nov 27, 2012·Updated Jul 8, 2019

In Brief

A Phase 4 clinical trial evaluating Anidulafungin for Candidemia. Completed, enrolled 85 participants across 1 site.

Detailed Summary

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help. Therefore, the objectives of this study are: 1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia; 2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidemia
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 27, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.6 years ago

Interventions

Anidulafungindrug

Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards