An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; Fungemia
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 serious Candida infection. 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 Patients With Candida Deep Tissue Infection
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
Secondary outcome: Percentage of Participants With Global Response at 2-week and 6-week Follow-up VisitPercentage of Participants With Response Based on Clinical Cure and Microbiological Success Percentage of Participants With Clinical Response Percentage of Participants With Relapse Percentage of Participants With New Infection Time to Negative Blood Culture Percentage of Participants With All-cause Mortality Time to Death
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a
culture specimen obtained from a normally sterile site accompanied by signs and
symptoms of infection.
- Male or female ≥ 16 years of age.
- Expected hospitalization for at least fourteen (14) 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, Antwerpen 2060, Belgium
Pfizer Investigational Site, Bruxelles 1000, Belgium
Pfizer Investigational Site, Bruxelles 1070, Belgium
Pfizer Investigational Site, Bruxelles 1200, Belgium
Pfizer Investigational Site, Sofia 1606, Bulgaria
Pfizer Investigational Site, Amsterdam 1081 HZ, Netherlands
Pfizer Investigational Site, Amsterdam 1091 AC, Netherlands
Pfizer Investigational Site, Nijmegen 6532 SZ, Netherlands
Pfizer Investigational Site, Coimbra 3040-853, Portugal
Pfizer Investigational Site, Lisboa 1150-199, Portugal
Pfizer Investigational Site, Bucuresti 014461, Romania
Pfizer Investigational Site, P/o Stepanovskoe, Krasnogorskiy District, Moscow Region 143423, Russian Federation
Pfizer Investigational Site, Geneve 14 CH-1211, Switzerland
Pfizer Investigational Site, Vancouver, British Columbia V6Z 1Y6, Canada
Pfizer Investigational Site, Newark, Delaware 19713, United States
Pfizer Investigational Site, Newark, Delaware 19718, United States
Pfizer Investigational Site, Wilmington, Delaware 19801, United States
Pfizer Investigational Site, Detroit, Michigan 48202, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2009
Last updated: May 30, 2013
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