An interventional study of NGS Analysis in Resistance Bacterial, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Diagnostic
This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 36 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Residual anonymized samples stored at -80°C at the Tropica Biobank of the DITM and for which diagnostic analysis for germ infection has previously been carried out at the DITM by blood culture and MDR surveillance in routine diagnostic rectal swab will be used. DNA extraction will be carried out on these residual samples (with subsequent quality and quantification analysis of the nucleic acid) for subsequent NGS analyses.
Diagnostic Test: NGS Analysis
An analytical pipeline with NGS technology developed in the GENRES study will be used for the identification of infecting microorganisms and the drug resistance they carry. For this purpose, a sequencing method will be identified and adopted that can obtain gene sequences of approximately 75 bp in length and on the Illumina MiSeq platform. Furthermore, IT software and bioinformatics analyzes with specific quality control parameters (pre- and post-alignment of reads) will be identified and adopted in order to develop an IVD system that includes a complete package of sequencing kits and software.
Microorganism presence (positive/negative)
Microorganism presence identified by NGS technology.
Time frame: Baseline
Microorganism identification
Microorganism identification obtained using NGS technology.
Time frame: Baseline
Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible)
Results (resistant/susceptible) obtained using NGS technology in the identification of gene mutations that convey resistance to antibiotics.
Time frame: Baseline
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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IRCCS Sacro Cuore Don Calabria di Negrar