Anti-mold Azole in the Prophylaxis for Invasive Fusariosis (Fusarproph)
Primary Purpose
Fusariosis, Onychomycosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Voriconazole or posaconazole
Sponsored by
About this trial
This is an interventional prevention trial for Fusariosis focused on measuring Prophylaxis
Eligibility Criteria
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
Sites / Locations
- Federal University of Rio de Janeiro
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
observational
Anti-mold prophylaxis
Arm Description
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02714504
First Posted
March 8, 2016
Last Updated
January 23, 2018
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT02714504
Brief Title
Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
Acronym
Fusarproph
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fusariosis, Onychomycosis
Keywords
Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
observational
Arm Type
No Intervention
Arm Description
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
Arm Title
Anti-mold prophylaxis
Arm Type
Experimental
Arm Description
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Intervention Type
Drug
Intervention Name(s)
Voriconazole or posaconazole
Intervention Description
Azole with activity against molds
Primary Outcome Measure Information:
Title
Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery
Description
Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks
Time Frame
Until neutrophil recovery, for an average of 4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941913
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
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