Clinical Research Directory
Browse clinical research sites, groups, and studies.
Diagnostic Performance and Acceptability of Rectal Swab for Screening of ESBL Enterobacterales
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
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
Official title: Diagnostic Performance and Acceptability of a Self-collected Rectal Swab for Screening of β Lactamase Extended Spectrum Enterobacterales
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-01-12
Completion Date
2028-01-01
Last Updated
2026-09-29
Healthy Volunteers
No
Interventions
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
Locations (1)
IRCCS Sacro Cuore Don Calabria Hospital
Negrar, Verona, Italy