Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE) 


Tracking Information

Start Date  ICMJEJuly 2008
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2008)		The primary efficacy endpoint will be the global treatment response at the End of Treatment. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00689338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: May 29, 2008)
  • Global response at the End of Intra Venous Treatment, at 2 weeks after End of Treatment and at 6 weeks after End of Treatment. [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
  • Time to first negative blood/tissue culture (defined as first negative culture which is not followed by positive culture within the next 3 days). [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
  • Day 90 survival [ Time Frame: up to 100 days ] [ Designated as safety issue: No ]
  • Time to ICU discharge. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
  • Incidence of adverse events and discontinuation from study treatment. [ Time Frame: up to 56 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAnidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Official Title  ICMJEOpen-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations
Brief Summary

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Candida
  • Candidiasis
Intervention  ICMJE
  • Drug: Anidulafungin
    Anidulafungin Intravenous Administration
  • Drug: Fluconazole
    Oral Administration of Fluconazole
  • Drug: Voriconazole
    Oral Administration of Voriconazole
Study Arms / Comparison GroupsTreatment Group: Experimental
Option to treat with oral azole therapy following treatment with anidulafungin
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
  • Drug: Voriconazole

Recruitment Information

Estimated Enrollment  ICMJE286
Estimated Completion DateMay 2010
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

  • Post-abdominal surgery.
  • Elderly > 65 years old.
  • Renal insufficiency / failure / hemodialysis.
  • Solid tumor.
  • Solid-organ (liver, kidney, lung, heart) transplant recipients.
  • Hepatic insufficiency.
  • Neutropenic including hematology oncology patients.

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEAustria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00689338
Responsible PartyClinical Trials Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA8851019
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer