Clinical Trial: This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

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

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

Brief Summary: The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment [ Time Frame: End of Treatment (EOT) (up to Day 42) ]

Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).


Original Primary Outcome:

  • The primary efficacy endpoint will be a global response rate, which will be determined based on the investigator assessed clinical response and microbiological response at the end of all study therapy (EOT).
  • The assessment of global response to treatment will be measured using a combination of the clinical response definitions of cure, improvement, indeterminate or failure; and microbiological response definitions of eradication, presumed eradication,
  • persistence and presumed persistence.


Current Secondary Outcome:

  • Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) [ Time Frame: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up ]
    Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
  • Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT [ Time Frame: Baseline, EIVT (up to Day 42) ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.
  • Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT [ Time Frame: Baseline, EOT (up to Day 42) ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.
  • Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up [ Time Frame: Baseline, Week 2 Follow-up ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.
  • Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT [ Time Frame: Baseline, EOT (up to Day 42) ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
  • Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT [ Time Frame: EIVT (up to Day 42) ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
  • Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up [ Time Frame: Baseline, Week 2 Follow-up (F/U) ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
  • Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score [ Time Frame: EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up ]
    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in

    Original Secondary Outcome:

    • Global response rate at the end of IV treatment (EIVT) and at Week 2 follow-up visit.
    • Global response rate per type of Candida species isolated.
    • Global response rate per baseline risk factors for candidemia/invasive Candidiasis.
    • Global response rate per pre-specified subgroups of interest at EOT (Patients with abdominal surgery, solid organ transplant, renal insufficiency, on chemotherapy, with
    • central venous catheter, neutropenic status and elderly).
    • Global response according the APACHE II score9.
    • 30-day survival rate.
    • Attributable mortality regarding candidemia/invasive candidiasis status.
    • Time to obtaining negative blood or specimen/tissue culture.
    • Time to switch to oral voriconazole therapy.
    • Length of hospital stay.
    • Length of ICU stay.
    • Incidence of adverse events (AEs) and discontinuations from the study.
    • Changes from baseline in vital signs and clinical laboratory parameters.


    Information By: Pfizer

    Dates:
    Date Received: October 19, 2007
    Date Started: February 2008
    Date Completion:
    Last Updated: December 15, 2010
    Last Verified: December 2010