Clinical Trial: Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive

Brief Summary: To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Detailed Summary:
Sponsor: Pfizer

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

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).


Original Primary Outcome: The primary efficacy endpoint will be the global treatment response at the End of Treatment. [ Time Frame: up to 56 days ]

Current Secondary Outcome:

  • Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) [ Time Frame: EOIVT (Day 10 up to Day 42) ]
    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).
  • 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) ]
    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).
  • 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) ]
    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 to First Negative Blood Culture [ Time Frame: Day 1 up to Day 42 ]
    Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.
  • Day 90 Survival [ Time Frame: Day 90 ]
    Percentage of participants known or assumed to be alive on Day 90.
  • Time to Successful Intensive Care Unit (ICU) Discharge [ Time Frame: Day 1 up to Day 56 ]
    Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.


Original Secondary Outcome:

  • Global response at the End of Intra Venous Treatment, at 2 weeks after End of Treatment and at 6 weeks after End of Treatment. [ Time Frame: up to 14 weeks ]
  • Time to first negative blood/tissue culture (defined as first negative culture which is not followed by positive culture within the next 3 days). [ Time Frame: up to 56 days ]
  • Day 90 Survival [ Time Frame: up to 100 days ]
  • Time to ICU discharge. [ Time Frame: up to 56 days ]
  • Incidence of adverse events and discontinuation from study treatment. [ Time Frame: up to 56 days ]


Information By: Pfizer

Dates:
Date Received: May 29, 2008
Date Started: July 2008
Date Completion:
Last Updated: May 25, 2011
Last Verified: May 2011