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
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