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

NCT06308692 | Recruiting

• 1 other identifier: 2022-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Resistant Bacterial Infection

Outcome Measures

Primary Outcomes (1)

• PCR results

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

  Baseline

Secondary Outcomes (1)

• Gene mutations

  Baseline

Study Arms (1)

Biological samples

OTHER

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.

Diagnostic Test: ARES PCR

Interventions

ARES PCR DIAGNOSTIC_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.

Biological samples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: June 28, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IT (1)