Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

NCT ID: NCT02714504

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Fusariosis; Onychomycosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

observational

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anti-mold prophylaxis

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

Group Type: EXPERIMENTAL

Voriconazole or posaconazole

Intervention Type: DRUG

Azole with activity against molds

Interventions

Voriconazole or posaconazole

Azole with activity against molds

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Marcio Nucci

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

Fusarium prophylaxis

Identifier Type: -

Identifier Source: org_study_id