Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

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NCT00531479

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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]izer.com
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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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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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

- Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;

- Diagnosis of possible, probable, or proven invasive aspergillosis.

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


- Patients with aspergilloma or chronic aspergillosis


- Receipt of 4 or more days of systemic antifungal treatment for the current episode of
invasive aspergillosis


- Anticipated survival of less than 5 days or Karnofsky score <=20

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AspergillosisAnidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
NCT00531479
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Little Rock, Arkansas
  4. La Jolla, California
  5. LaJolla, California
  6. San Diego, California
  7. San Francisco, California
  8. Gainesville, Florida
  9. Miami, Florida
  10. Atlanta, Georgia
  11. Chicago, Illinois
  12. Chicago, Illinois
  13. Baltimore, Maryland
  14. Baltimore, Maryland
  15. Baltimore, Maryland
  16. Baltimore, Maryland
  17. Detroit, Michigan
  18. Detroit, Michigan
  19. Rochester, New York
  20. Chapel Hill, North Carolina
  21. Winston-Salem, North Carolina
  22. Portland, Oregon
  23. Philadelphia, Pennsylvania
  24. Houston, Texas
  25. Seattle, Washington
  26. Seattle, Washington
  27. Westmead, New South Wales
  28. Herston, Queensland
  29. Adelaide, South Australia
  30. Brugge,
  31. Bruxelles,
  32. Leuven,
  33. Yvoir,
  34. Curitiba, PR
  35. Rio de Janeiro, RJ
  36. Porto Alegre, RS
  37. Winnipeg, Manitoba
  38. Winnipeg, Manitoba
  39. Hamilton, Ontario
  40. Hamilton, Ontario
  41. Montreal, Quebec
  42. Quebec,
  43. Praha 2,
  44. Nantes, Cedex 01
  45. Marseille, Cedex 09
  46. Brest,
  47. Creteil,
  48. GRENOBLE Cedex 09,
  49. Paris,
  50. Rouen Cedex,
  51. Strasbourg,
  52. Berlin,
  53. Berlin,
  54. Bremen,
  55. Dresden,
  56. Frankfurt (Oder),
  57. Hamburg,
  58. Heidelberg,
  59. Homburg/Saar,
  60. Koeln,
  61. Mainz,
  62. Muenchen,
  63. Wuerzburg,
  64. Thessaloniki,
  65. Pune, Maharashtra
  66. Cuneo,
  67. Genova,
  68. Milano,
  69. Milano,
  70. Perugia,
  71. Pescara,
  72. Roma,
  73. Seoul,
  74. Seoul,
  75. Seoul,
  76. Seoul,
  77. Seoul,
  78. RC Leiden,
  79. Lima,
  80. Gdansk,
  81. Warszawa,
  82. Lisboa,
  83. Lisboa,
  84. Moscow,
  85. Moscow,
  86. Moscow,
  87. Saint Petersburg,
  88. Singapore,
  89. Singapore,
  90. Badalona, Barcelona
  91. Madrid,
  92. Madrid,
  93. Salamanca,
  94. Valencia,
  95. Valencia,
  96. Geneve 14,
  97. Lausanne,
  98. Kuei-Shan Hsiang, Taoyuan County
  99. Kaohsiung,
  100. Taipei,
  101. Bangkok,
  102. Bangkok,
  103. Bangkok,
  104. Adana,
  105. Ankara,
  106. London,
  107. Manchester,
ALL GENDERS
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AspergillosisStudy to Test the Combination of Voriconazole and Anidulafungin in Patients Who Have, or Are Thought to Have, Invasive Aspergillosis and Who Are Unable to Take a Common Antifungal Therapy (Polyene)
NCT00620074
  1. Atlanta, Georgia
  2. Detroit, Michigan
  3. Fort Worth, Texas
  4. Fort Worth, Texas
ALL GENDERS
18 Years+
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MULTIPLE SITES
AspergillosisVoriconazole For Chronic Bronchopulmonary Aspergillosis
NCT00159822
  1. Nantes, Cedex
  2. Angers Cedex,
  3. Bobigny,
  4. Brest Cedex,
  5. Bris Sous Forges,
  6. Caen Cedex,
  7. Dinan Cedex,
  8. Grenoble Cedex 09,
  9. Lille Cedex,
  10. Lyon Cedex,
  11. Montpellier Cedex 5,
  12. Paris Cedex 18,
  13. Paris Cedex 20,
  14. Paris,
  15. Poitiers Cedex,
  16. Reims Cedex,
  17. Rouen Cedex,
  18. Suresnes,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AspergillosisA Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).
NCT00037206
  1. King of Prussia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Official Title  ICMJE A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis
Brief Summary This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aspergillosis
Intervention  ICMJE
  • Drug: voriconazole

    First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.

    Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.

    Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,

    OR

    Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Other Name: Vfend
  • Drug: anidulafungin

    First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

    Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

    Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

    OR

    Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Other Name: Eraxis
  • Drug: voriconazole

    First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.

    Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.

    Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,

    OR

    Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

    Other Name: Vfend
Study Arms  ICMJE
  • Active Comparator: Voriconazole
    Voriconazole monotherapy
    Intervention: Drug: voriconazole
  • Experimental: Voriconazole and Anidulafungin
    Combination therapy with voriconazole and anidulafungin
    Interventions:
    • Drug: anidulafungin
    • Drug: 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: April 3, 2012)		459
Original Enrollment  ICMJE
 (submitted: September 14, 2007)		335
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
  • Diagnosis of possible, probable, or proven invasive aspergillosis.

Exclusion Criteria:

  • Patients with aspergilloma or chronic aspergillosis
  • Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
  • Anticipated survival of less than 5 days or Karnofsky score <=20
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, 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 Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries Austria,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT00531479
Other Study ID Numbers  ICMJE A8851009
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 April 2012

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