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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:
ClinicalTrials.gov Identifier:
NCT00496197
First Posted: July 4, 2007
Last Update Posted: October 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: May 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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 
Other                14 
Protocol Violation                8 



  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) 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 
Overall Participants Analyzed 
[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) ]

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

3.  Secondary:   Number of Participants With Microbiological Response at EOT   [ Time Frame: End of Treatment (Day 5 up to Day 42) ]

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) ]

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

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

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 ]

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

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

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) ]

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

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

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) ]

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) ]

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 ]

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) ]

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) ]

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

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00496197     History of Changes
Other Study ID Numbers: A8851011
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: May 12, 2011
Results First Posted: October 3, 2011
Last Update Posted: October 3, 2011