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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungemia; Neutropenia; Candidiasis

Intervention: Active Anidulafungin (Drug); Active Caspofungin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Global Response at End of Intravenous Treatment (EOIVT)

Secondary outcome:

Global Response at End of Treatment (EOT)

Global Response at 2-Week Follow-Up Visit

Global Response at 6-Week Follow-Up Visit

Response Based on Clinical Cure and Microbiological Success at EOIVT

Response Based on Clinical Cure and Microbiological Success at EOT

Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit

Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit

Clinical Response at Day 10

Number of Participants With Recurrence

Number of Participants With New Infections

Time to First Negative Blood Culture for Candida Species

Time to Death

All-Cause Mortality

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Sarajevo 71000, Bosnia and Herzegovina

Pfizer Investigational Site, GRENOBLE Cedex 09 38043, France

Pfizer Investigational Site, Strasbourg Cedex 67098, France

Pfizer Investigational Site, Bologna 40138, Italy

Pfizer Investigational Site, Roma 00133, Italy

Pfizer Investigational Site, Gdansk 80-952, Poland

Pfizer Investigational Site, Warszawa 02-776, Poland

Pfizer Investigational Site, Wroclaw 50-367, Poland

Pfizer Investigational Site, Moscow 115478, Russian Federation

Pfizer Investigational Site, Kosice 04190, Slovakia

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2009
Last updated: November 20, 2012

Page last updated: August 20, 2015

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