Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods

IRCCS Sacro Cuore Don Calabria di Negrar100 enrolled

Overview

Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank. The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR. The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Drug Resistant Bacterial Infection

Interventions

ARES PCRDIAGNOSTIC_TEST

Real time PCR assays will be used for the identification of infecting microorganisms and the drug resistance they carry that allow their identification, such as KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR. The validation of the method will be carried out in 100 (based on availability in Tropica Biobank) clinical samples: blood n=50 (positive, as for the negatives reference will be made to those already provided in the GENRES study) and rectal swabs ( positive n=40 and negative n=10) provided by the DITM. Sensitivity and specificity will be analyzed. As a reference for positivity and negativity data, reference will be made to routine diagnostic data obtained through standard operating procedures at the DITM laboratories.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 at the Tropica Biobank has been signed Exclusion criteria: * Absence of data relating to positivity or negativity to the germs of interest * Absence of stored residual material * Absence of information and consent to the conservation of biological samples for signed research purposes

Outcomes

Primary Outcomes

PCR results

Results (positive/negative and microorganism identification) obtained by real time PCR.

Time frame: Baseline

Secondary Outcomes

Gene mutations

Results (resistant/susceptible) obtained by real time PCR in the identification of gene mutations that convey resistance to antibiotics.