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Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE)

Primary Purpose

Invasive Candidiasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anidulafungin
Fluconazole
Voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Candidiasis focused on measuring Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit, Anidulafungin, Ecalta, Eraxis, Fluconazole, Voriconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Option to treat with oral azole therapy following treatment with anidulafungin

Outcomes

Primary Outcome Measures

Percentage of Participants With Global Treatment Response Success at End of Treatment
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).

Secondary Outcome Measures

Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
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).
Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment
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).
Percentage of Participants With Global Response Success 6 Weeks After End of Treatment
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).
Time to First Negative Blood Culture
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 90 Survival
Percentage of participants known or assumed to be alive on Day 90.
Time to Successful Intensive Care Unit (ICU) Discharge
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.

Full Information

First Posted
May 29, 2008
Last Updated
May 25, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00689338
Brief Title
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Acronym
ICE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Candidiasis
Keywords
Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit, Anidulafungin, Ecalta, Eraxis, Fluconazole, Voriconazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Option to treat with oral azole therapy following treatment with anidulafungin
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Intervention Description
Anidulafungin Intravenous Administration
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Oral Administration of Fluconazole
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
Oral Administration of Voriconazole
Primary Outcome Measure Information:
Title
Percentage of Participants With Global Treatment Response Success at End of Treatment
Description
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).
Time Frame
End of Treatment (Day 14 to Day 56)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
Description
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).
Time Frame
EOIVT (Day 10 up to Day 42)
Title
Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment
Description
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).
Time Frame
2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)
Title
Percentage of Participants With Global Response Success 6 Weeks After End of Treatment
Description
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).
Time Frame
6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)
Title
Time to First Negative Blood Culture
Description
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.
Time Frame
Day 1 up to Day 42
Title
Day 90 Survival
Description
Percentage of participants known or assumed to be alive on Day 90.
Time Frame
Day 90
Title
Time to Successful Intensive Care Unit (ICU) Discharge
Description
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.
Time Frame
Day 1 up to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Koebenhavn OE
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Pfizer Investigational Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69433
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif Cedex
ZIP/Postal Code
94804
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kifisia
State/Province
Athens
ZIP/Postal Code
14561
Country
Greece
Facility Name
Pfizer Investigational Site
City
Haidari
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10143
Country
Italy
Facility Name
Pfizer Investigational Site
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Ede
ZIP/Postal Code
6716 RP
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3040-853
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Pfizer Investigational Site
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
033 10
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Gorukle
State/Province
Bursa
ZIP/Postal Code
16045
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49600
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
84003
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33891293
Citation
De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
Results Reference
derived
PubMed Identifier
31280481
Citation
Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
Results Reference
derived
PubMed Identifier
28597967
Citation
Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
Results Reference
derived
PubMed Identifier
28459966
Citation
Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851019&StudyName=Anidulafungin%20Candidemia/Invasive%20Candidiasis%20Intensive%20Care%20Study%0A
Description
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Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

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