Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods
NCT ID: NCT06308692
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-06-28
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 stored residual material
* Absence of information and consent to the conservation of biological samples for signed research purposes
ALL
No
Sponsors
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IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
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Locations
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IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy
Countries
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Facility Contacts
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Other Identifiers
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2022-11
Identifier Type: -
Identifier Source: org_study_id
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