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

Not Applicable

Recruiting

• Conditions: Resistance Bacterial
• Interventions: Diagnostic Test: NGS Analysis

• Registration Number: NCT06322173
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-28
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NGS analysis	NGS Analysis	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.

Primary Outcome Measures

Name	Time	Method
Microorganism presence (positive/negative)	Baseline	Microorganism presence identified by NGS technology.
Microorganism identification	Baseline	Microorganism identification obtained using NGS technology.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria hospital; 🇮🇹 Negrar, Verona, Italy