Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00496197
First received: July 3, 2007
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.


Condition Intervention Phase
Candidiasis
Drug: Eraxis (anidulafungin)
Drug: Diflucan (fluconazole)
Drug: Vfend (voriconazole)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) [ Time Frame: End of Treatment (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).


Secondary Outcome Measures:
  • Number of Participants With Clinical Response at EOT [ Time Frame: End of Treatment (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.

  • Number of Participants With Microbiological Response at EOT [ Time Frame: End of Treatment (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).

  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV) [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Clinical Response at EOIV [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ] [ Designated as safety issue: No ]
    Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.

  • Number of Participants With Microbiological Response at EOIV [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ] [ Designated as safety issue: No ]
    Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).

  • Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up [ Time Frame: Week 2 Follow-up ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up [ Time Frame: Week 2 follow-up ] [ Designated as safety issue: No ]
    Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.

  • Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up [ Time Frame: Week 2 Follow-up ] [ Designated as safety issue: No ]
    Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).

  • Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS]) [ Time Frame: Week 6 Follow-up (EOS) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS) [ Time Frame: Week 6 follow-up (EOS) ] [ Designated as safety issue: No ]
    Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.

  • Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS) [ Time Frame: Week 6 Follow-up (EOS) ] [ Designated as safety issue: No ]
    Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).

  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline [ Time Frame: End of Treatment (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline [ Time Frame: End of Intravenous treatment (Day 5 up to Day 28) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline [ Time Frame: Week 2 Follow-up ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline [ Time Frame: Week 6 Follow-up (EOS) ] [ Designated as safety issue: No ]
    Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

  • Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species [ Time Frame: Baseline (Day 1) up to Week 6 Follow-up (EOS) ] [ Designated as safety issue: No ]
    Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.

  • Medical Resource Utilization (MRU): Duration of Hospital Stay (Days) [ Time Frame: Baseline up to 6 Week Follow-up (EOS) ] [ Designated as safety issue: No ]
    Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.

  • Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days) [ Time Frame: Baseline up to 6 Week Follow-up (EOS) ] [ Designated as safety issue: No ]
    Analysis of length of hospital stay based on Kaplan-Meier survival techniques.

  • Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days) [ Time Frame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28) ] [ Designated as safety issue: No ]
    Analysis of length of hospital stay based on Kaplan-Meier survival techniques.

  • Medical Resource Utilization (MRU): Duration of Overall Therapy (Days) [ Time Frame: Baseline up to End of Treatment (Day 5 up to Day 42) ] [ Designated as safety issue: No ]
    Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.

  • Number of Participants Per Specified Cause of Death [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ] [ Designated as safety issue: Yes ]
    Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.

  • Number of Participants With Non-serious and Serious Adverse Events [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ] [ Designated as safety issue: Yes ]
    AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.

  • Number of Participants Who Died [ Time Frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
Drug: Eraxis (anidulafungin)
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
Other Name: Eraxis (anidulafungin)
Drug: Diflucan (fluconazole)
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.
Other Name: Diflucan (fluconazole)
Drug: Vfend (voriconazole)
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
Other Name: Vfend (voriconazole)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects > or equal to 18 years of age.
  • Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
  • Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion Criteria:

  • Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
  • Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
  • Subjects with infected prosthetic devices which cannot be removed within 24 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496197

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
San Francisco, California, United States, 94143
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
Pfizer Investigational Site
Newark, Delaware, United States, 19718
Pfizer Investigational Site
Wilmington, Delaware, United States, 19801
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
Orlando, Florida, United States, 32819
Pfizer Investigational Site
Orlando, Florida, United States, 32801
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Pfizer Investigational Site
Springfield, Illinois, United States, 62701
Pfizer Investigational Site
Springfield, Illinois, United States, 62702
Pfizer Investigational Site
Springfield, Illinois, United States, 62703
Pfizer Investigational Site
Springfield, Illinois, United States, 62703-9248
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21205
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Pfizer Investigational Site
Minnesota, Minnesota, United States, 55455
United States, Montana
Pfizer Investigational Site
Butte, Montana, United States, 59701
United States, New Jersey
Pfizer Investigational Site
Camden, New Jersey, United States, 08103
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12208
Pfizer Investigational Site
Buffalo, New York, United States, 14263
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834
Pfizer Investigational Site
Greenville, North Carolina, United States, 27834-6028
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29414
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00496197     History of Changes
Other Study ID Numbers: A8851011
Study First Received: July 3, 2007
Results First Received: May 12, 2011
Last Updated: August 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
candidemia
invasive candidiasis
fungal bloodstream infection

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Candidemia
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014