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

Pfizer logo

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)

45 participants in 1 patient group

1
Experimental group
Treatment:
Drug: voriconazole

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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