Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

Onychomycosis Clinical Trial

— Fusarproph  

Official title:

Evaluation of the Efficacy of Anti-mold Azole Prophylaxis in High-risk Hematologic Patients With Baseline Superficial Skin Lesions Positive for Fusarium Spp

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714504
• Other study ID #: Fusarium prophylaxis
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fusariosis
• Onychomycosis

Intervention

Drug:
• Voriconazole or posaconazole
Azole with activity against molds

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Until neutrophil recovery, for an average of 4 weeks