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

Phase 4CompletedNCT00143312

Pfizer45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prophylaxis Of Invasive Fungal Infections

Interventions

voriconazoleDRUG

Voriconazole is given to patients at least 48 hours after chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Pfizer Investigational Site

Leuven, Belgium

Pfizer Investigational Site

Marseille, Cedex 09, France

Outcomes

Primary Outcomes

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit

Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up

Time frame: 12 months

Secondary Outcomes

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit

Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up

Time frame: 6 months

Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit

Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit

Time frame: 150 days

Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)

Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.

Time frame: 12 months

Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)

Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.

Time frame: 12 months

Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)

Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.

Data from ClinicalTrials.gov

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