Resistance Bacterial
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTNGS 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.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital * Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or * Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).
Exclusion criteria
* Absence of data relating to positivity or negativity to the germs of interest * Absence of stored residual material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microorganism presence (positive/negative) | Baseline | Microorganism presence identified by NGS technology. |
| Microorganism identification | Baseline | Microorganism identification obtained using NGS technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible) | Baseline | Results (resistant/susceptible) obtained using NGS technology in the identification of gene mutations that convey resistance to antibiotics. |
Countries
Italy
Outcome results
None listed