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

Study Overview
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Brief Summary
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To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

Official Title
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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).

Conditions
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Prophylaxis Of Invasive Fungal Infections

Intervention / Treatment
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* Drug: voriconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: voriconazole<br>* Voriconazole is given to patients at least 48 hours after chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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. | 12 months | 
| Survival Without Proven or Probable Invasive Fungal Infection (IFI) | Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits | 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Fungal Infection, Allogenic Stem Cell Transplant, prophylaxis, leukemia, voriconazole