Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods

Resistance Bacterial Clinical Trial

— ARES_NGS  

Official title:

Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322173
• Other study ID #: 2022-13
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Resistance Bacterial

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microorganism presence (positive/negative)	Microorganism presence identified by NGS technology.	Baseline
Primary	Microorganism identification	Microorganism identification obtained using NGS technology.	Baseline
Secondary	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.	Baseline