Diagnostic Performance and Acceptability of Rectal Swab for Screening of ESBL Enterobacterales

Condition(s) studied

Investigational drug(s) / intervention(s)

Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse: Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection. The molecular test will be performed on the ELITe InGenius platform, an integrated system that automatically performs nucleic acid extraction, real-time polymerase chain reaction (PCR) and interpretation of results in less than 3 h. The amplification analysis will be performed using the ESBL ELITe MGB kit. This is a qualitative multiplex real-time PCR assays for the detection of the most prevalent ESBL-encoding genes in Enterobacterales. This assay utilizes 200 µl of sample; after DNA extraction, the InGenius platform sets up the PCR using 20 µl of DNA, 10 µl of Internal Control and 20 µl of PCR Mix. At the end of the sample collection, the patient will be given a questionnaire on the acceptability of the self-administered rectal swab which must be completed by the end of hospitalization

Study summary

The goal of this interventional study without drugs and medical devices is to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales

Eligibility

Primary outcome measure(s)

• Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales — 24 hours after swabs collection

Trial sites (1)

More IRCCS Sacro Cuore Don Calabria di Negrar trials in Italy