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 Negrar

Status: Enrolling

Conditions: Drug Resistant Bacterial Infection

Treatments: Diagnostic Test: ARES PCR

Study type: Interventional

Funder types: Other

Identifiers

NCT06308692

2022-11

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Biological samples

Other group

Description:

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.

Treatment:

Diagnostic Test: ARES PCR