At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 54 enrolled

Drug / intervention

Anidulafungin +1 moredrug

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/NCT00548262

NCT00548262Phase 4Completed

Compare CT.gov

Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients

Pfizer·interventional·Posted Oct 23, 2007·Updated Jan 17, 2011

In Brief

A Phase 4 clinical trial evaluating Anidulafungin and Voriconazole for Candidemia and Invasive Candidiasis. Completed, enrolled 54 participants across 13 sites in 5 countries.

Detailed Summary

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCandidemia, Invasive Candidiasis

CountriesBrazil, Chile, Colombia, Mexico, Panama

Collaborators--

Timeline

Phase 4CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedOct 2007

Enrollment StartFeb 2008

Primary CompletionOct 2009

TodayJul 2026

First PostedOct 23, 2007

Enrollment StartFeb 1, 2008

Primary CompletionOct 1, 2009

TodayJul 2, 2026

Enrollment to primary: 1.7 yearsPosted 18.7 years ago

Interventions

Anidulafungindrug

All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.

Voriconazoledrug

Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if \<40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if \<40 kg body weight).