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

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

• Efficacy of Voriconazole as secondary prophylaxis on rate of occurrence of proven and probable invasive fungal infection up to 12 months follow up
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• To evaluate time to occurrence of proven/probable new (new pathogen) IFIs from the start of voriconazole prophylaxis.
  • Time Frame: 12 months
    Safety Issue?: No
• To evaluate the safety and tolerability of voriconazole as secondary prophylaxis after allogenic SCT.
  • Time Frame: 12 months
    Safety Issue?: No
• To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable IFI from the start of voriconazole prophylaxis until the End of Prophylaxis visit.
  • Time Frame: 150 days
    Safety Issue?: No
• To evaluate time to occurrence of proven/probable recurrent (same pathogen as previous IFI) IFIs from the start of voriconazole prophylaxis.
  • Time Frame: 12 months
    Safety Issue?: No
• Efficacy at 6 months FU; Efficacy until EOP visit; Evaluate time to/of IFI; Evaluate proportion of patients experiencing proven/probable recurrent/new IFI's; Survival free at 6 and 12 months; Safety and tolerability
  • Time Frame: 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 October 10, 2008

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

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