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

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NCT00496197

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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NCT00496197
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  4. Los Angeles, California
  5. San Francisco, California
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  7. Newark, Delaware
  8. Newark, Delaware
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  10. Washington, District of Columbia
  11. Jacksonville, Florida
  12. Miami, Florida
  13. Orlando, Florida
  14. Orlando, Florida
  15. Orlando, Florida
  16. Atlanta, Georgia
  17. Springfield, Illinois
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  20. Springfield, Illinois
  21. Baltimore, Maryland
  22. Baltimore, Maryland
  23. Detroit, Michigan
  24. Detroit, Michigan
  25. Royal Oak, Michigan
  26. Minnesota, Minnesota
  27. Butte, Montana
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  31. Rochester, New York
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
Official Title  ICMJE Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Candidiasis
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE Experimental: 1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
Interventions:
  • Drug: Eraxis (anidulafungin)
  • Drug: Diflucan (fluconazole)
  • Drug: Vfend (voriconazole)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2010)		282
Original Enrollment  ICMJE
 (submitted: July 3, 2007)		300
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00496197
Other Study ID Numbers  ICMJE A8851011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP