Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00689338
First received: May 29, 2008
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Invasive Candidiasis
Drug: Anidulafungin
Drug: Fluconazole
Drug: Voriconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Global Treatment Response Success at End of Treatment [ Time Frame: End of Treatment (Day 14 to Day 56) ] [ Designated as safety issue: No ]
    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) [ Time Frame: EOIVT (Day 10 up to Day 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 up to Day 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Percentage of participants known or assumed to be alive on Day 90.

  • Time to Successful Intensive Care Unit (ICU) Discharge [ Time Frame: Day 1 up to Day 56 ] [ Designated as safety issue: No ]
    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.


Enrollment: 216
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689338

  Show 61 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00689338     History of Changes
Other Study ID Numbers: A8851019
Study First Received: May 29, 2008
Results First Received: April 21, 2011
Last Updated: May 25, 2011
Health Authority: United Kingdom: Department of Health

Keywords provided by Pfizer:
Candida
Candidemia
Systemic Candidiasis
ICU
Intensive Care Unit
Critical Care Unit
Anidulafungin
Ecalta
Eraxis
Fluconazole
Voriconazole

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anidulafungin
Echinocandins
Voriconazole
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014