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
Results First Received: April 21, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Invasive Candidiasis
Interventions: Drug: Anidulafungin
Drug: Fluconazole
Drug: Voriconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult specific participants were recruited from intensive care unit (ICU) populations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two-hundred twenty one (221) participants were screened; 5 participants were screen failures who did not receive study medication.

Reporting Groups
  Description
Anidulafungin Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.

Participant Flow:   Overall Study
    Anidulafungin  
STARTED     216  
COMPLETED     73  
NOT COMPLETED     143  
Death                 65  
Adverse Event                 13  
Insufficient Clinical Response                 1  
Lack of Efficacy                 6  
Unspecified                 8  
Did not Meet Entrance Criteria                 27  
Lost to Follow-up                 5  
Withdrawal by Subject                 3  
Protocol Violation                 15  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anidulafungin Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.

Baseline Measures
    Anidulafungin  
Number of Participants  
[units: participants]
  216  
Age, Customized  
[units: participants]
 
<18 years     0  
18 to 44 years     27  
45 to 64 years     89  
≥ 65 years     100  
Gender  
[units: participants]
 
Female     85  
Male     131  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Global Treatment Response Success at End of Treatment   [ Time Frame: End of Treatment (Day 14 to Day 56) ]

2.  Secondary:   Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)   [ Time Frame: EOIVT (Day 10 up to Day 42) ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)
Measure 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
MITT; N excludes participants with missing or unknown global responses.

Reporting Groups
  Description
Anidulafungin Anidulafungin: 200 milligrams (mg) Day 1, 100 mg once daily from Day 2 (minimum of 9 days, maximum of 41 days). After Day 10 option to treat with oral azole therapy (voriconazole or fluconazole) at a dose determined by local clinical practice up to a maximum of 56 days from Day 1.

Measured Values
    Anidulafungin  
Number of Participants Analyzed  
[units: participants]
  157  
Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)  
[units: percentage¬†of¬†participants]
Number ( 95% Confidence Interval )
  70.7  
  ( 62.9 to 77.7 )  

No statistical analysis provided for Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)



3.  Secondary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   Time to First Negative Blood Culture   [ Time Frame: Day 1 up to Day 42 ]

6.  Secondary:   Day 90 Survival   [ Time Frame: Day 90 ]

7.  Secondary:   Time to Successful Intensive Care Unit (ICU) Discharge   [ Time Frame: Day 1 up to Day 56 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In a change to the protocol, time to first negative blood/tissue culture will only concern time to first negative blood culture. Lack of regular tissue sampling meant that analysis of time to first tissue culture could not be meaningfully performed.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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