Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects

ConditionInfection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: male and female subjects aged between 18 and 45 years who use PrEP

Trial outcomes

Primary outcomes

1

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/).

Time frame
At enrolment

Secondary outcomes

1

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/).

Time frame
At enrolment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.