- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00496197
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
August 29, 2011 updated by: Pfizer
Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 138-736
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 135-710
- Pfizer Investigational Site
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Seoul, Korea, Republic of, 137-701
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Pfizer Investigational Site
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Birmingham, Alabama, United States, 35294
- Pfizer Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Pfizer Investigational Site
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California
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Los Angeles, California, United States, 90033
- Pfizer Investigational Site
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San Francisco, California, United States, 94115
- Pfizer Investigational Site
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San Francisco, California, United States, 94143
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, United States, 19718
- Pfizer Investigational Site
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Newark, Delaware, United States, 19713
- Pfizer Investigational Site
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Wilmington, Delaware, United States, 19801
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Pfizer Investigational Site
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Florida
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Jacksonville, Florida, United States, 32209
- Pfizer Investigational Site
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Miami, Florida, United States, 33136
- Pfizer Investigational Site
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Orlando, Florida, United States, 32806
- Pfizer Investigational Site
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Orlando, Florida, United States, 32801
- Pfizer Investigational Site
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Orlando, Florida, United States, 32819
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Pfizer Investigational Site
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Illinois
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Springfield, Illinois, United States, 62701
- Pfizer Investigational Site
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Springfield, Illinois, United States, 62702
- Pfizer Investigational Site
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Springfield, Illinois, United States, 62703-9248
- Pfizer Investigational Site
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Springfield, Illinois, United States, 62703
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21205
- Pfizer Investigational Site
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Baltimore, Maryland, United States, 21287
- Pfizer Investigational Site
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Michigan
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Detroit, Michigan, United States, 48202
- Pfizer Investigational Site
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Detroit, Michigan, United States, 48201
- Pfizer Investigational Site
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Royal Oak, Michigan, United States, 48073
- Pfizer Investigational Site
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Minnesota
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Minnesota, Minnesota, United States, 55455
- Pfizer Investigational Site
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Montana
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Butte, Montana, United States, 59701
- Pfizer Investigational Site
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New Jersey
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Camden, New Jersey, United States, 08103
- Pfizer Investigational Site
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New York
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Albany, New York, United States, 12208
- Pfizer Investigational Site
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Buffalo, New York, United States, 14263
- Pfizer Investigational Site
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Rochester, New York, United States, 14642
- Pfizer Investigational Site
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North Carolina
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Greenville, North Carolina, United States, 27834
- Pfizer Investigational Site
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Greenville, North Carolina, United States, 27834-6028
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, United States, 97239
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15213
- Pfizer Investigational Site
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West Reading, Pennsylvania, United States, 19611
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29414
- Pfizer Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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).
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End of Treatment (Day 5 up to Day 42)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Response at EOT
Time Frame: End of Treatment (Day 5 up to Day 42)
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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.
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End of Treatment (Day 5 up to Day 42)
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Number of Participants With Microbiological Response at EOT
Time Frame: End of Treatment (Day 5 up to Day 42)
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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).
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End of Treatment (Day 5 up to Day 42)
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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)
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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).
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End of Intravenous treatment (Day 5 up to Day 28)
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Number of Participants With Clinical Response at EOIV
Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
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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.
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End of Intravenous treatment (Day 5 up to Day 28)
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Number of Participants With Microbiological Response at EOIV
Time Frame: End of Intravenous treatment (Day 5 up to Day 28)
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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).
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End of Intravenous treatment (Day 5 up to Day 28)
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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
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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).
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Week 2 Follow-up
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Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Time Frame: Week 2 follow-up
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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.
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Week 2 follow-up
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Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Time Frame: Week 2 Follow-up
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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).
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Week 2 Follow-up
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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)
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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).
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Week 6 Follow-up (EOS)
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Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Time Frame: Week 6 follow-up (EOS)
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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.
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Week 6 follow-up (EOS)
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Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Time Frame: Week 6 Follow-up (EOS)
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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).
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Week 6 Follow-up (EOS)
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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)
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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).
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End of Treatment (Day 5 up to Day 42)
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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)
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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).
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End of Intravenous treatment (Day 5 up to Day 28)
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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
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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).
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Week 2 Follow-up
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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)
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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).
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Week 6 Follow-up (EOS)
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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)
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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.
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Baseline (Day 1) up to Week 6 Follow-up (EOS)
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Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
Time Frame: Baseline up to 6 Week Follow-up (EOS)
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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.
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Baseline up to 6 Week Follow-up (EOS)
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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)
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Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
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Baseline up to 6 Week Follow-up (EOS)
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Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
Time Frame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
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Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
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Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
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Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
Time Frame: Baseline up to End of Treatment (Day 5 up to Day 42)
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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.
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Baseline up to End of Treatment (Day 5 up to Day 42)
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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)
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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.
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Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
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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)
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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.
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Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
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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)
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Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
- Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
- Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
- Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
- Vazquez J, Reboli AC, Pappas PG, Patterson TF, Reinhardt J, Chin-Hong P, Tobin E, Kett DH, Biswas P, Swanson R. Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial. BMC Infect Dis. 2014 Feb 21;14:97. doi: 10.1186/1471-2334-14-97.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 3, 2007
First Submitted That Met QC Criteria
July 3, 2007
First Posted (Estimate)
July 4, 2007
Study Record Updates
Last Update Posted (Estimate)
October 3, 2011
Last Update Submitted That Met QC Criteria
August 29, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Bacterial Infections and Mycoses
- Sepsis
- Mycoses
- Invasive Fungal Infections
- Fungemia
- Candidiasis
- Candidemia
- Candidiasis, Invasive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Anidulafungin
- Fluconazole
- Voriconazole
Other Study ID Numbers
- A8851011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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