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: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

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.

Link to ClinicalStudyResults.org