Anti-mold Azole in the Prophylaxis for Invasive Fusariosis
Fusarproph
Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp
1 other identifier
interventional
239
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedResults Posted
Study results publicly available
September 21, 2018
CompletedSeptember 21, 2018
January 1, 2018
6.3 years
March 8, 2016
January 23, 2018
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
observational
NO INTERVENTIONNo anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
Anti-mold prophylaxis
EXPERIMENTALAnti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior documentation of invasive fusariosis or allergy to azoles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941913, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Marcio Nucci
- Organization
- Univ Fed Rio de Janeiro
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 21, 2016
Study Start
August 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 21, 2018
Results First Posted
September 21, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share