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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
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fusariosis focused on measuring Prophylaxis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 8, 2016
Last Updated
January 23, 2018
Sponsor
Universidade Federal do Rio de Janeiro
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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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