An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

This study has been terminated.
(The study was prematurely terminated on May 18, 2012 due to slow enrollment. The study was not terminate due to any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00806351
First received: November 26, 2008
Last updated: November 20, 2012
Last verified: November 2012
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Fungemia
Neutropenia
Candidiasis
Interventions: Drug: Active Anidulafungin
Drug: Active Caspofungin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anidulafungin Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
Caspofungin Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.

Participant Flow:   Overall Study
    Anidulafungin     Caspofungin  
STARTED     15     6  
COMPLETED     10     2  
NOT COMPLETED     5     4  
Death                 5                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
Caspofungin Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
Total Total of all reporting groups

Baseline Measures
    Anidulafungin     Caspofungin     Total  
Number of Participants  
[units: participants]
  15     6     21  
Age, Customized  
[units: participants]
     
18 to 44 years     2     2     4  
45 to 64 years     9     2     11  
greater than or equal to (≥) 65 years     4     2     6  
Gender  
[units: participants]
     
Female     6     3     9  
Male     9     3     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Global Response at End of Intravenous Treatment (EOIVT)   [ Time Frame: Day 10 up to Day 42 ]

2.  Secondary:   Global Response at End of Treatment (EOT)   [ Time Frame: Day 14 up to Day 56 ]

3.  Secondary:   Global Response at 2-Week Follow-Up Visit   [ Time Frame: 2 weeks post treatment ]

4.  Secondary:   Global Response at 6-Week Follow-Up Visit   [ Time Frame: 6 weeks post treatment ]

5.  Secondary:   Response Based on Clinical Cure and Microbiological Success at EOIVT   [ Time Frame: Day 10 up to Day 42 ]

6.  Secondary:   Response Based on Clinical Cure and Microbiological Success at EOT   [ Time Frame: Day 14 up to Day 56 ]

7.  Secondary:   Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit   [ Time Frame: 2 weeks post treatment ]

8.  Secondary:   Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit   [ Time Frame: 6 weeks post treatment ]

9.  Secondary:   Clinical Response at Day 10   [ Time Frame: Day 10 ]

10.  Secondary:   Number of Participants With Recurrence   [ Time Frame: 2 and 6 weeks post treatment ]

11.  Secondary:   Number of Participants With New Infections   [ Time Frame: 2 and 6 weeks post treatment ]

12.  Secondary:   Time to First Negative Blood Culture for Candida Species   [ Time Frame: Baseline up to Day 56 ]

13.  Secondary:   Time to Death   [ Time Frame: Day 1 up to Day 98 ]

14.  Secondary:   All-Cause Mortality   [ Time Frame: Baseline up to 6 weeks post treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
Study prematurely terminated due to slow enrollment, not due to safety issues. Meaningful interpretation and comparison of treatment outcomes with caspofungin was difficult due to low number of participants (n=3) with confirmed Candida infection.  


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: NCT00806351     History of Changes
Other Study ID Numbers: A8851021
Study First Received: November 26, 2008
Results First Received: November 20, 2012
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration