Anti-mold Azole in the Prophylaxis for Invasive Fusariosis (Fusarproph)

Universidade Federal do Rio de Janeiro

Status: Completed

Conditions: Fusariosis; Onychomycosis

Treatments: Drug: Voriconazole or posaconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02714504

Fusarium prophylaxis

Details and patient eligibility

About

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

Full 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.

Enrollment: 239 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 2 patient groups

observational

No Intervention group

Description:

No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions

Anti-mold prophylaxis

Experimental group

Description:

Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.

Treatment:

Drug: Voriconazole or posaconazole