Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

Study Overview
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Brief Summary
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Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

Detailed Description
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Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and >30 days elapses from one to other admission (episode). Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs. In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started. Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

Official Title
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Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp

Conditions
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Fusariosis, Onychomycosis

Intervention / Treatment
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* Drug: Voriconazole or posaconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia Exclusion Criteria: prior documentation of invasive fusariosis or allergy to azoles
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: observational<br>No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions | |
| Experimental: Anti-mold prophylaxis<br>Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp. | Drug: Voriconazole or posaconazole<br>* Azole with activity against molds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery | Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks | Until neutrophil recovery, for an average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis