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

March 6, 2024 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria hospital
        • Contact:
        • Principal Investigator:
          • Elena Pomari
        • Sub-Investigator:
          • Pierantonio Orza
        • Sub-Investigator:
          • Francesca Perandin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biological samples
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCR results
Time Frame: Baseline
Results (positive/negative and microorganism identification) obtained by real time PCR.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene mutations
Time Frame: Baseline
Results (resistant/susceptible) obtained by real time PCR in the identification of gene mutations that convey resistance to antibiotics.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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