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Report for Clinical Trial NCT03024281

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Surveillance of Azole Resistance in Aspergillus

Primary objectives: 1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates collected in participating hospitals in Taiwan 2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates in Taiwan 3. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in Taiwan 4. To investigate the clonality of Aspergillus clinical and environmental isolates in Taiwan 5. To describe the genetic relationships between local resistant strains with global strains Secondary objective: 1. To describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis 2. To evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study

NCT03024281 Infection; Aspergillus
MeSH: Aspergillosis


Primary Outcomes

Description: The proportion of patients with complete response or partial response according to the definition described in "Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. Sep 1 2008;47(5):674-683."

Measure: Treatment success

Time: 6 weeks after diagnosis of proven or probable invasive aspergillosis

Secondary Outcomes

Description: The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.

Measure: All-cause mortality

Time: 6 weeks after diagnosis of proven or probable invasive aspergillosis

Description: The proportion of non-survivors. Discharge against medical advice and in critical condition and lost to follow up will categorized as mortality.

Measure: All-cause mortality

Time: 12 weeks after diagnosis of proven or probable invasive aspergillosis

Description: The proportion of patients with breakthrough mold infections

Measure: Breakthrough mold infections

Time: 6 weeks after diagnosis of proven or probable invasive aspergillosis

Description: The proportion of patients with breakthrough invasive fungal diseases defined as occurrence of a proven or probable invasive fungal diseases according to EORTC/MSG revised definitions while on systemic antifungal therapy or within 15 days of discontinuation of antifungal use

Measure: Breakthrough invasive fungal diseases

Time: 12 weeks after diagnosis of proven or probable invasive aspergillosis

Description: The proportion of patients with complete response or partial response.

Measure: Treatment success

Time: 12 weeks after diagnosis of proven or probable invasive aspergillosis

Time Perspective: Retrospective

Case-Only


There is one SNP

SNPs


1 L98H

Multiple amino acid substitutions in the cyp51A gene have been described to be associated with azole resistance that emerges during azole treatment, while a resistance mechanism, TR34/L98H mutation in cyp51A, has been linked to the agricultural use of azole fungicides in Europe, which have also been widely used in Taiwan for years. --- L98H ---



HPO Nodes