Clinical Trial: Anidulafungin In Treatment Of Candidemia In Asian Subjects

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

Official Title: A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients

Brief Summary: The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Subjects With Global Response of Success at End of Treatment [ Time Frame: End of treatment (EOT) = Day 5 up to Day 42 ]

Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.


Original Primary Outcome: To evaluate the clinical efficacy of anidulafungin (in terms of global response to treatment at End of All Treatment, EOT) in the treatment of Asian subjects with candidemia.

Current Secondary Outcome:

  • Number of Subjects With Global Response of Success at Endpoints [ Time Frame: End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) ]
    Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.
  • Number of Subjects With Clinical Response of Success at Endpoints [ Time Frame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline ]
    Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.
  • Number of Subjects With Microbiological Response of Success at Endpoints [ Time Frame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline ]
    Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.
  • Time to Death From Any Cause [ Time Frame: Baseline through end of 12 weeks after baseline ]
    Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
  • Time to Death Due to Candidemia [ Time Frame: Baseline through end of 12 weeks after baseline ]
    Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).
  • Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ]
    Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.
  • Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ]
    Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).
  • Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment [ Time Frame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) ]
    Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persis

    Original Secondary Outcome:

    • To evaluate efficacy of anidulafungin in terms of global response at the end of intravenous treatment (EOIT), 2, 6 weeks after EOT and at the end of 12 weeks from baseline.
    • To evaluate the clinical and microbiological responses at EOIT, EOT, 2 and 6 weeks after EOT and at the end of 12 weeks from baseline.
    • To assess all cause mortality and mortality related to candidemia.
    • To characterize the relationship between Beta-D-glucan assay results and overall clinical and microbiological responses.
    • To allow characterization of the benefit of anidulafungin in terms of global response in pre-specified subgroups of interest at EOT.
    • To demonstrate the safety and tolerability of anidulafungin in the treatment of Asian patients with candidemia.


    Information By: Pfizer

    Dates:
    Date Received: September 25, 2007
    Date Started: January 2008
    Date Completion:
    Last Updated: March 4, 2010
    Last Verified: March 2010