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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 Visit

Percentage 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

Page last updated: August 20, 2015

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