About this trial
The importance of the study lies mainly in expanding knowledge of the phenomenon of antibiotic resistance in subjects using PrEP, studying for the first time in this population the resistance phenotype in commensal Enterobacterales of the gastrointestinal tract.
The data obtained from this study could pave the way for potential surveillance and awareness programs for the critical and conscious use of antimicrobials in PrEP subjects in order to mitigate the problem of antibiotic resistance, which currently represents a real global challenge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18 and 45 years
HIV-negative subjects undergoing an anorectal swab for Chlamydia trachomatis and Neisseria gonorrhoeae using NAAT as a normal diagnostic-assistance procedure provided for subjects using PrEP
Disqualifiers
none
Trial population
male and female subjects aged between 18 and 45 years who use PrEP and who go to the dedicated clinics of the Infectious Diseases Unit of the IRCCS - University Hospital of Bologna for normal check-ups/follow-ups Patients will be treated in accordance with their normal care process and the results of the study-specific laboratory analyses provided for by this protocol will in no way influence the diagnostic-therapeutic path of the patients.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of antibiotic-resistant Enterobacterales strains
Percentage of resistant strains out of the total strains isolated for each individual antimicrobial based on MICs obtained by a phenotypic antibiogram in broth micro-dilution, compared with criteria by EUCAST guidelines (www.eucast.org/).
Secondary outcomes
Prevalence of antibiotic-resistant Enterobacterales strains
Percentage of resistant strains out of the total strains isolated for each individual antimicrobial based on MICs obtained by a phenotypic antibiogram in broth micro-dilution, compared with criteria by EUCAST guidelines (www.eucast.org/).
Sponsors and contacts
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