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An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Supportive care Approved-not yet active 16 and over Pharmaceutical / Industry A8851021
NCT00806351

Trial Description

Summary

The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Eligibility Criteria

Inclusion Criteria:

Dysfunctional immune system (reduced neutrophils); Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection; Male of female ≥16 years of age; Expected hospitalization for at least ten (10) days.

Exclusion Criteria:

Pregnancy or breast feeding or planning to become pregnant during the study; Recent treatment with one of the study drugs over the last 30 days; Allergy to either study drug or to this class of drugs; Significant liver dysfunction; Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Pfizer CT.gov Call Center

Ph: 1-800-718-1021

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00806351
Information obtained from ClinicalTrials.gov on April 26, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.