Status:

TERMINATED

An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

Lead Sponsor:

Pfizer

Conditions:

Candidiasis

Fungemia

Eligibility:

All Genders

16+ years

Phase:

PHASE3

Brief 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 effecti...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2012

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT00805740

Start Date

April 1 2009

End Date

June 1 2012

Last Update

August 1 2013

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Pfizer Investigational Site

Newark, Delaware, United States, 19713

2

Pfizer Investigational Site

Newark, Delaware, United States, 19718

3

Pfizer Investigational Site

Wilmington, Delaware, United States, 19801

4

Pfizer Investigational Site

Detroit, Michigan, United States, 48202