SNPMiner Trials by Shray Alag

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Report for Mutation Y121F

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials

1 PCR Based Detection of Azole Resistance in A. Fumigatus to Improve Patient Outcome. A Prospective Multicenter Observational Study.

A standard treatment protocol for invasive aspergillosis (IA) will be implemented in several academic hematology centers in the Netherlands in which a diagnostic test demonstrating azole resistance by multiplex real-time polymerase chain reaction will guide the choice of appropriate antifungal treatment. Objectives: 1. Improve the outcome of patients infected with azole resistant A. fumigatus by the early detection of Resistance Associated Mutations (RAMs) and with this the earlier initiation of the most appropriate therapy. 2. Monitor the prevalence of invasive aspergillosis due to strains carrying the TR34/L98H or the TR46/T289A/Y121F resistance associated mutations in the Netherlands.

NCT03121235 Aspergillosis, Invasive Pulmonary Diagnostic Test: PCR based detection of azole resistance in A. fumigatus
MeSH:Aspergillosis Invasive Pulmonary Aspergillosis

2. Monitor the prevalence of invasive aspergillosis due to strains carrying the TR34/L98H or the TR46/T289A/Y121F resistance associated mutations in the Netherlands. --- L98H --- --- Y121F ---

Primary Outcomes

Description: Incidence of antifungal treatment failure in patients with the presence of RAM detected by the AsperGenius® resistance PCR. This incidence will be compared with a fixed failure rate set at 75%, based on the observed treatment failure in patients treated with voriconazole that were shown to carry azole resistant A. fumigatus.

Measure: Incidence of antifungal treatment failure

Time: 12 weeks

Secondary Outcomes

Description: This will be compared with a fixed mortality of 50%.

Measure: Demonstrate that early detection of azole resistance reduces the overall mortality.

Time: 6 weeks

Description: Posaconazole step down therapy will be considered effective if <35% of the patients treated with posaconazole oral monotherapy show progression of their invasive aspergillosis after documented response after at least 14 days of IV antifungal therapy.

Measure: Demonstrate that a step down to oral posaconazole is a reasonable treatment option in patients that have responded to at least 2 weeks of IV antifungal therapy.

Time: 12 weeks

Description: A group that received appropriate antifungal therapy soon will be compared with a group that received treatment late.

Measure: Comparison of antifungal treatment failure in patients with the presence of RAM.

Time: 24 weeks

2 Prospective Multi-center Surveillance Study on the Prevalence of Azole-resistant Aspergillus Spp. in Clinical Isolates ot Patients With Pulmonary Colonization or Invasive Infections in Switzerland

Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland

NCT03443336 Pulmonary Aspergillosis
MeSH:Aspergillosis Pulmonary Aspergillosis

These mutations, including TR34/L98H and TR46/Y121F/T289A have been identified in the environment and have been demonstrated to cause resistance to azole fungicides used in agriculture. --- L98H --- --- Y121F ---

Primary Outcomes

Description: Distribution of antifungal susceptibility profile of all tracheal and urinary samples in clinical Aspergillus isolates

Measure: Azole-resistance in Aspergillus (A.) fumigatus

Time: start of study until end of study (July 2017 until December 2018)

HPO Nodes