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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Prophylaxis Of Invasive Fungal Infections

Treatments: Drug: voriconazole

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00143312

A1501038

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

1

Experimental group

Treatment:

Drug: voriconazole