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Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00496197
First received: July 3, 2007
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
Results First Received: May 12, 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: Candidiasis
Interventions: Drug: Eraxis (anidulafungin)
Drug: Diflucan (fluconazole)
Drug: Vfend (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Anidulafungin Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.

Participant Flow:   Overall Study
    Anidulafungin  
STARTED     282  
COMPLETED     160  
NOT COMPLETED     122  
Discontinued study due to death                 43  
Adverse Event                 13  
Does not meet entrance criteria                 5  
Insufficient clinical response                 3  
Insufficient bacteriological response                 10  
Lost to Follow-up                 11  
Withdrawal by Subject                 11  
Pathogen not isolated baseline specimen                 4  
Unspecified                 14  
Protocol Violation                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Anidulafungin Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.

Baseline Measures
    Anidulafungin  
Number of Participants  
[units: participants]
 		  282  
Age, Customized  
[units: participants]
 		 
18 to 44 years of age     72  
45 to 64 years of age     116  
≥ 65 years of age     94  
Gender  
[units: participants]
 		 
Female     131  
Male     151  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)   [ Time Frame: End of Treatment (Day 5 up to Day 42) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Clinical Response at EOT   [ Time Frame: End of Treatment (Day 5 up to Day 42) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Microbiological Response at EOT   [ Time Frame: End of Treatment (Day 5 up to Day 42) ]
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4.  Secondary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)   [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Clinical Response at EOIV   [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Microbiological Response at EOIV   [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up   [ Time Frame: Week 2 Follow-up ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up   [ Time Frame: Week 2 follow-up ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up   [ Time Frame: Week 2 Follow-up ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])   [ Time Frame: Week 6 Follow-up (EOS) ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)   [ Time Frame: Week 6 follow-up (EOS) ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)   [ Time Frame: Week 6 Follow-up (EOS) ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline   [ Time Frame: End of Treatment (Day 5 up to Day 42) ]
  Show Outcome Measure 13

14.  Secondary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline   [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ]
  Show Outcome Measure 14

15.  Secondary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline   [ Time Frame: Week 2 Follow-up ]
  Show Outcome Measure 15

16.  Secondary:   Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline   [ Time Frame: Week 6 Follow-up (EOS) ]
  Show Outcome Measure 16

17.  Secondary:   Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species   [ Time Frame: Baseline (Day 1) up to Week 6 Follow-up (EOS) ]
  Show Outcome Measure 17

18.  Secondary:   Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)   [ Time Frame: Baseline up to 6 Week Follow-up (EOS) ]
  Show Outcome Measure 18

19.  Secondary:   Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)   [ Time Frame: Baseline up to 6 Week Follow-up (EOS) ]
  Show Outcome Measure 19

20.  Secondary:   Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)   [ Time Frame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28) ]
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21.  Secondary:   Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)   [ Time Frame: Baseline up to End of Treatment (Day 5 up to Day 42) ]
  Show Outcome Measure 21

22.  Secondary:   Number of Participants Per Specified Cause of Death   [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ]
  Show Outcome Measure 22

23.  Secondary:   Number of Participants With Non-serious and Serious Adverse Events   [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ]
  Show Outcome Measure 23

24.  Secondary:   Number of Participants Who Died   [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ]
  Show Outcome Measure 24


  Serious Adverse Events
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  Other Adverse Events
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  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
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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: Pfizer
ClinicalTrials.gov Identifier: NCT00496197     History of Changes
Other Study ID Numbers: A8851011
Study First Received: July 3, 2007
Results First Received: May 12, 2011
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration