Antibiotic resistance in gut Enterobacterales from people on PrEP
Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects
This project will test bacteria from rectal swabs of people on PrEP to see which antibiotics their gut Enterobacterales are resistant to.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT07370948 on ClinicalTrials.gov |
What this trial studies
ENTERO-PrEP is an observational, single-center, cross-sectional tissue study enrolling HIV-negative adults at the Infectious Diseases Unit of the IRCCS - University Hospital of Bologna. During a scheduled anorectal swab for Chlamydia and gonorrhea screening, researchers will culture commensal Enterobacterales from the same swab without requiring additional sampling. Isolates will undergo broth microdilution antibiograms at the hospital microbiology unit, and participants will complete a brief questionnaire about personal and behavioral risk factors. Each person is recruited once and the results will be used to map resistance phenotypes in this PrEP population to inform surveillance and stewardship efforts.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative adults aged 18–45 who are using PrEP and are having an anorectal swab as part of routine STI monitoring.
Not a fit: People who are HIV-positive, not taking PrEP, outside the 18–45 age range, or who do not undergo an anorectal swab will not benefit from this study's findings directly.
Why it matters
Potential benefit: If successful, the results could help design surveillance and antibiotic stewardship programs to reduce the spread of resistant gut bacteria among people on PrEP.
How similar studies have performed: Surveillance of Enterobacterales resistance in other populations has provided useful data for stewardship, but this is the first dedicated assessment of commensal gut Enterobacterales specifically in PrEP users.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Claudio Foschi, MD
- Email: claudio.foschi2@unibo.it
- Phone: +39 0512144515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.