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

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ClinicalTrials.gov Identifier: NCT02714504
Recruitment Status : Completed
First Posted : March 21, 2016
Results First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Marcio Nucci, 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

Condition or disease Intervention/treatment Phase
Fusariosis Onychomycosis Drug: Voriconazole or posaconazole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : August 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: observational
No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions
Experimental: Anti-mold prophylaxis
Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Drug: Voriconazole or posaconazole
Azole with activity against molds




Primary Outcome Measures :
  1. Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714504


Locations
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Brazil
Federal University of Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 21941913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
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Responsible Party: Marcio Nucci, Associate Professor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02714504    
Other Study ID Numbers: Fusarium prophylaxis
First Posted: March 21, 2016    Key Record Dates
Results First Posted: September 21, 2018
Last Update Posted: September 21, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcio Nucci, Universidade Federal do Rio de Janeiro:
Prophylaxis
Additional relevant MeSH terms:
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Onychomycosis
Fusariosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Hyalohyphomycosis
Voriconazole
Posaconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents