Clinical Trial: An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection

Brief Summary: The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42) [ Time Frame: End of Treatment (Day 14 to Day 42) ]

Original Primary Outcome: Global response at the end of treatment (EOT) in the modified intent-to-teat (MITT) group [ Time Frame: At end of treatment (Day 14 - 42) ]

Current Secondary Outcome:

• Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit [ Time Frame: 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT) ]
  Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
• Percentage of Participants With Response Based on Clinical Cure and Microbiological Success [ Time Frame: EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) ]
  A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.
• Percentage of Participants With Clinical Response [ Time Frame: Day 10 ]
  A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.
• Percentage of Participants With Relapse [ Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) ]
  Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.
• Percentage of Participants With New Infection [ Time Frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) ]
  New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.
• Time to Negative Blood Culture [ Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT) ]
  Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.
• Percentage of Participants With All-cause Mortality [ Time Frame: Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT) ]
  All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.
• Time to Death [ Time Frame: Baseline up to 6-week follow-up (6 weeks after EOT) ]
  Time to death (days) was assessed as date of death minus first treatment date plus 1.

Original Secondary Outcome:

• Response based on clinical cure and microbiological success at EOT, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 42) and at the 2-week and 6-week follow-up visit ]
• Time to negative blood culture (if subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 84) ]
• Safety [ Time Frame: During and at end of study (Day 0 - 84) ]
• Time to death [ Time Frame: During and at end of study (Day 0 - 84) ]
• All cause mortality during study therapy and follow-up visits [ Time Frame: During and at end of study (Day 0 - 84) ]
• Clinical response at Day 10 [ Time Frame: At Day 10 of treatment ]
• Rates of relapse at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ]
• Rates of new infection with an organism not identified at baseline and the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ]
• Global response at the 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At the 2-week and 6-week follow-up visit ]

Dates:
Date Received: November 26, 2008
Date Started: April 2009
Date Completion:
Last Updated: May 30, 2013
Last Verified: May 2013