- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714504
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 21941913
- Federal University of Rio de Janeiro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Azole with activity against molds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Until neutrophil recovery, for an average of 4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Tinea
- Dermatomycoses
- Nail Diseases
- Hyalohyphomycosis
- Onychomycosis
- Fusariosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- 14-alpha Demethylase Inhibitors
- Trypanocidal Agents
- Posaconazole
- Voriconazole
Other Study ID Numbers
- Fusarium prophylaxis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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