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


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateApril 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 9, 2008)		Global response at the end of treatment (EOT) in the modified intent-to-teat (MITT) group [ Time Frame: At end of treatment (Day 14 - 42) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00805740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 9, 2008)
  • All cause mortality during study therapy and follow-up visits [ Time Frame: During and at end of study (Day 0 - 84) ] [ Designated as safety issue: No ]
  • Clinical response at Day 10 [ Time Frame: At Day 10 of treatment ] [ Designated as safety issue: No ]
  • Rates of relapse at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Rates of new infection with an organism not identified at baseline and the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Global response at the 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Response based on clinical cure and microbiological success at EOT, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 42) and at the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Time to negative blood culture (if subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 84) ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: During and at end of study (Day 0 - 84) ] [ Designated as safety issue: Yes ]
  • Time to death [ Time Frame: During and at end of study (Day 0 - 84) ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEAn Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
Official Title  ICMJEEfficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection
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 effective as the comparator drug, caspofungin.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Candidiasis
  • Fungemia
Intervention  ICMJE
  • Drug: Active anidulafungin
    Subjects in this arm will receive active anidulafungin and placebo caspofungin
  • Drug: Active Caspofungin
    Subjects in this arm will receive active caspofungin and placebo anidulafungin
Study Arms / Comparison Groups
  • Anidulafungin arm: Experimental
    Intervention: Drug: Active anidulafungin
  • Caspofungin arm: Experimental
    Intervention: Drug: Active Caspofungin

Recruitment Information

Estimated Enrollment  ICMJE45
Estimated Completion DateApril 2012
Estimated Primary Completion DateApril 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEBelgium,   Bulgaria,   Canada,   Netherlands,   Portugal,   Russian Federation,   Switzerland

Administrative Information

NCT ID  ICMJENCT00805740
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA8851022
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer