Anti-mold Azole in the Prophylaxis for Invasive Fusariosis (Fusarproph)
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|ClinicalTrials.gov Identifier: NCT02714504|
Recruitment Status : Completed
First Posted : March 21, 2016
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fusariosis Onychomycosis||Drug: Voriconazole or posaconazole||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: observational
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
Experimental: Anti-mold prophylaxis
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
Azole with activity against molds
- Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery [ Time Frame: Until neutrophil recovery, for an average of 4 weeks ]Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714504
|Federal University of Rio de Janeiro|
|Rio de Janeiro, RJ, Brazil, 21941913|