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


Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateOctober 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2008)		Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy in the modified intent to treat (MITT) group [ Time Frame: At end of intravenous treatment (Day 10 - 42) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00806351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 9, 2008)
  • Response (based on clinical cure and microbiologic success) at the end of intravenous treatment, end of treatment, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 56) and at the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Clinical response at Day 10 of treatment [ 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 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 ]
  • Global response at end of treatment, and 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 ]
  • Time to negative blood culture (if the subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
  • Time to death [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
  • All cause mortality during the study therapy and at follow visits [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]
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 Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
Official Title  ICMJEEfficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection
Brief 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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Fungemia
  • Neutropenia
  • Candidiasis
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 DateOctober 2012
Estimated Primary Completion DateOctober 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEBulgaria,   Canada,   France,   Italy,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Switzerland

Administrative Information

NCT ID  ICMJENCT00806351
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA8851021
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer