Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

NCT00689338

Last updated date
Study Location
Pfizer Investigational Site
Wien, , A-1090, Austria
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

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.
Invasive 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

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

- Post-abdominal surgery.

- Elderly > 65 years old.

- Renal insufficiency / failure / hemodialysis.

- Solid tumor.

- Solid-organ (liver, kidney, lung, heart) transplant recipients.

- Hepatic insufficiency.

- Neutropenic including hematology oncology patients.

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


Patients with poor venous access that would preclude IV drug delivery or multiple blood
draws.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Invasive CandidiasisAnidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
NCT00689338
  1. Wien,
  2. Brussels,
  3. Brussel,
  4. Gent,
  5. Leuven,
  6. Liege,
  7. Yvoir,
  8. Hamilton, Ontario
  9. Hamilton, Ontario
  10. Quebec,
  11. Brno,
  12. Ostrava,
  13. Praha 10,
  14. Koebenhavn OE,
  15. Odense C,
  16. Amiens,
  17. Bordeaux,
  18. Clichy,
  19. Lyon,
  20. Marseille,
  21. Montpellier,
  22. Paris Cedex 18,
  23. Villejuif Cedex,
  24. Berlin,
  25. Freiburg,
  26. Wuppertal,
  27. Kifisia, Athens
  28. Haidari, Attiki
  29. Budapest,
  30. Budapest,
  31. Pisa,
  32. Roma,
  33. Roma,
  34. Torino,
  35. Udine,
  36. Ede,
  37. Rotterdam,
  38. Krakow,
  39. Lodz,
  40. Coimbra,
  41. Lisboa,
  42. Porto,
  43. Porto,
  44. Bucuresti,
  45. Iasi,
  46. Moscow,
  47. Moscow,
  48. Moscow,
  49. Saint-Petersburg,
  50. Saint-Petersburg,
  51. Bratislava,
  52. Bratislava,
  53. Kosice,
  54. Gorukle, Bursa
  55. Ankara,
  56. Trabzon,
  57. Dnipropetrovsk,
  58. Donetsk,
  59. Leeds, West Yorkshire
  60. Liverpool,
  61. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Official Title  ICMJE Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations
Brief Summary To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Invasive Candidiasis
Intervention  ICMJE
  • Drug: Anidulafungin
    Anidulafungin Intravenous Administration
  • Drug: Fluconazole
    Oral Administration of Fluconazole
  • Drug: Voriconazole
    Oral Administration of Voriconazole
Study Arms  ICMJE Experimental: Treatment Group
Option to treat with oral azole therapy following treatment with anidulafungin
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
  • 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: September 3, 2010)
216
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2008)
286
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

  • Post-abdominal surgery.
  • Elderly > 65 years old.
  • Renal insufficiency / failure / hemodialysis.
  • Solid tumor.
  • Solid-organ (liver, kidney, lung, heart) transplant recipients.
  • Hepatic insufficiency.
  • Neutropenic including hematology oncology patients.

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

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 Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689338
Other Study ID Numbers  ICMJE A8851019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

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