Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

Not Applicable

Completed

• Conditions: Fusariosis; Onychomycosis
• Interventions: Drug: Voriconazole or posaconazole

• Registration Number: NCT02714504
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-21
• Status Verified: 2018-01
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Results First Posted: 2018-09-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil