Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

Verified by: Pfizer, September 2009
First Received: August 31, 2005 | Last Updated: September 23, 2009 | Phase: Phase 4 | Start Date: February 2005
Overall Status: Completed | Estimated Enrollment: 45
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To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell...

Brief Summary

Official Title: “Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).”

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

  • Drug: voriconazole
    • Voriconazole is given to patients at least 48 hours after chemotherapy

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
    • Time Frame: 12 months
      Safety Issue?: No

Secondary Measures

  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit
    • Time Frame: 6 months
      Safety Issue?: No
  • Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit
    • Time Frame: 150 days
      Safety Issue?: No
  • Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)
    • Time Frame: 12 months
      Safety Issue?: No
  • Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)
    • Time Frame: 12 months
      Safety Issue?: No
  • Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)
    • Time Frame: 12 months
      Safety Issue?: No
  • Survival Without Proven or Probable Invasive Fungal Infection (IFI)
    • Time Frame: 6 months, 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion Criteria:

  • Pregnant or lactating women
  • Severe disease other tham the underlying condition
  • Active, symptomatic uncontrolled Invasive Fungal Infection
  • Any evidence of active fungal disease as defined by MSG-EORTC criteria
  • Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
  • Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143312

Study ID Number: A1501038

ClinicalTrials.gov Identifier: NCT00143312

Health Authority: France: Afssaps - French Health Products Safety Agency

To obtain contact information for a study center near you, click here.

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