An interventional study of ARES PCR in Drug Resistant Bacterial Infection, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Diagnostic
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 36 studies on the registry; 22 are open to participants now.
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Exclusion criteria:
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.
PCR results
Results (positive/negative and microorganism identification) obtained by real time PCR.
Time frame: Baseline
Gene mutations
Results (resistant/susceptible) obtained by real time PCR in the identification of gene mutations that convey resistance to antibiotics.
Time frame: Baseline
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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IRCCS Sacro Cuore Don Calabria di Negrar