Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE)

May 25, 2011 updated by: Pfizer

Open-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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, A-1090
        • Pfizer Investigational Site
  • Belgium
      • Brussel, Belgium, 1090
        • Pfizer Investigational Site
      • Brussels, Belgium, B-1070
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, B-4000
        • Pfizer Investigational Site
      • Yvoir, Belgium, 5530
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Pfizer Investigational Site
      • Ostrava, Czech Republic, 708 52
        • Pfizer Investigational Site
      • Praha 10, Czech Republic, 100 34
        • Pfizer Investigational Site
  • Denmark
      • Koebenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
      • Odense C, Denmark, 5000
        • Pfizer Investigational Site
  • France
      • Amiens, France, 80054
        • Pfizer Investigational Site
      • Bordeaux, France, 33076
        • Pfizer Investigational Site
      • Clichy, France, 92110
        • Pfizer Investigational Site
      • Lyon, France, 69433
        • Pfizer Investigational Site
      • Marseille, France, 13385
        • Pfizer Investigational Site
      • Montpellier, France, 34295
        • Pfizer Investigational Site
      • Paris Cedex 18, France, 75877
        • Pfizer Investigational Site
      • Villejuif Cedex, France, 94804
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Wuppertal, Germany, 42283
        • Pfizer Investigational Site
  • Greece
    • Athens
      • Kifisia, Athens, Greece, 14561
        • Pfizer Investigational Site
    • Attiki
      • Haidari, Attiki, Greece, 12462
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Budapest, Hungary, 1106
        • Pfizer Investigational Site
  • Italy
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
      • Roma, Italy, 00168
        • Pfizer Investigational Site
      • Roma, Italy, 00161
        • Pfizer Investigational Site
      • Torino, Italy, 10143
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
  • Netherlands
      • Ede, Netherlands, 6716 RP
        • Pfizer Investigational Site
      • Rotterdam, Netherlands, 3083 AN
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland, 31-501
        • Pfizer Investigational Site
      • Lodz, Poland, 90-153
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3040-853
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1349-019
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-072
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-319
        • Pfizer Investigational Site
  • Romania
      • Bucuresti, Romania, 022328
        • Pfizer Investigational Site
      • Iasi, Romania, 700111
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 121552
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 125167
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 191015
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 194291
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 033 10
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 07
        • Pfizer Investigational Site
      • Kosice, Slovakia, 041 66
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Trabzon, Turkey, 61080
        • Pfizer Investigational Site
    • Bursa
      • Gorukle, Bursa, Turkey, 16045
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49600
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 84003
        • Pfizer Investigational Site
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Pfizer Investigational Site
      • London, United Kingdom, SE5 9RS
        • Pfizer Investigational Site
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
Drug: Anidulafungin
Anidulafungin Intravenous Administration
Drug: Fluconazole
Oral Administration of Fluconazole
Drug: Voriconazole
Oral Administration of Voriconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Global Treatment Response Success at End of Treatment
Time Frame: End of Treatment (Day 14 to Day 56)
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
End of Treatment (Day 14 to Day 56)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
Time Frame: EOIVT (Day 10 up to Day 42)
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
EOIVT (Day 10 up to Day 42)
Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment
Time Frame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)
Percentage of Participants With Global Response Success 6 Weeks After End of Treatment
Time Frame: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)
Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).
6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)
Time to First Negative Blood Culture
Time Frame: Day 1 up to Day 42
Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.
Day 1 up to Day 42
Day 90 Survival
Time Frame: Day 90
Percentage of participants known or assumed to be alive on Day 90.
Day 90
Time to Successful Intensive Care Unit (ICU) Discharge
Time Frame: Day 1 up to Day 56
Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.
Day 1 up to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

June 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 25, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8851019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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