β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

NCT00672841

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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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

- Age ≥18 years

- Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours

- IV access for administration of study drug

- Subject (or subject's legal representative) able to give written informed consent

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


- History of hypersensitivity or intolerance to echinocandin antifungals


- Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin)
greater than 10 times the upper limits of normal (ULN)


- Pregnant or lactating women


- Treatment with systemic antifungal therapy within the preceding 7 days


- Documented invasive fungal infection at baseline/screening


- Life expectancy less than 2 days or moribund

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Invasive CandidiasisAnidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
NCT00689338
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  5. Leuven,
  6. Liege,
  7. Yvoir,
  8. Hamilton, Ontario
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  10. Quebec,
  11. Brno,
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  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 ?-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
Official Title  ICMJE Randomized Comparison of ?-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit Patients
Brief Summary This is a single center, prospective, open label assessment of ?-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the ?-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the ?-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for ?-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, ?-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Invasive Candidiasis
Intervention  ICMJE
  • Drug: Preemptive Therapy with Anidulafungin
    Subjects in the active surveillance arm who develop a single positive ?-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days.
    Other Name: Eraxis
  • Drug: Empiric antifungal therapy based on physician discretion.
    Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.
Study Arms  ICMJE
  • Active Comparator: 2
    Standard care/empiric therapy group
    Intervention: Drug: Empiric antifungal therapy based on physician discretion.
  • Experimental: 1
    Active surveillance/ preemptive therapy group
    Intervention: Drug: Preemptive Therapy with Anidulafungin
Publications * Hanson KE, Pfeiffer CD, Lease ED, Balch AH, Zaas AK, Perfect JR, Alexander BD. ?-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study. PLoS One. 2012;7(8):e42282. doi: 10.1371/journal.pone.0042282. Epub 2012 Aug 6.

*   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: March 13, 2013)
64
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2008)
100
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ?18 years
  • Admission to the intensive care unit for ? 72 hours and expected to stay an additional 48 hours
  • IV access for administration of study drug
  • Subject (or subject's legal representative) able to give written informed consent

Exclusion Criteria:

  • History of hypersensitivity or intolerance to echinocandin antifungals
  • Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
  • Pregnant or lactating women
  • Treatment with systemic antifungal therapy within the preceding 7 days
  • Documented invasive fungal infection at baseline/screening
  • Life expectancy less than 2 days or moribund
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00672841
Other Study ID Numbers  ICMJE Pro00003161
GA88517X
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kimberly E Hanson, MDUtah
Principal Investigator:Barbara D Alexander, MDDuke
Principal Investigator:John Perfect, MDDuke
PRS Account Duke University
Verification Date November 2012

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