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Recruiting Observational

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

NCT07370948 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-05-30
Last updated
2026-01-27

Condition(s) studied

Infection

Study summary

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

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * none

Primary outcome measure(s)

  • Prevalence of antibiotic-resistant Enterobacterales strains — At enrolment
    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/).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07370948 on ClinicalTrials.gov ↗ ← All trials in Italy