Fusariosis, Onychomycosis
Conditions
Keywords
Prophylaxis
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.
Interventions
DRUGVoriconazole or posaconazole
Azole with activity against molds
Sponsors
Universidade Federal do Rio de Janeiro
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery | 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 |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions | 61 |
| Anti-mold Prophylaxis Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Voriconazole or posaconazole: Azole with activity against molds | 178 |
| Total | 239 |
Baseline characteristics
| Characteristic | Observational | Anti-mold Prophylaxis | Total |
|---|---|---|---|
| Age, Continuous Age | 44 years | 50 years | 48 years |
| Sex: Female, Male Female | 37 Participants | 109 Participants | 146 Participants |
| Sex: Female, Male Male | 24 Participants | 69 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 61 | 18 / 178 |
| other Total, other adverse events | 0 / 61 | 0 / 178 |
| serious Total, serious adverse events | 0 / 61 | 0 / 178 |
Outcome results
Primary
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
Time frame: Until neutrophil recovery, for an average of 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery | 6 Participants |
| Anti-mold Prophylaxis | Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery | 8 Participants |