Antibiotic resistance in gut Enterobacterales from people on PrEP
Official title: Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07370948 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | May 30, 2025 |
| Main results expected | February 15, 2026 |
| Study ends | February 28, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07370948 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Expanding HIV-positive donor livers for HIV-positive recipients
This study tests whether liver transplants from HIV-positive donors to HIV-positive recipients are safe regarding opportunistic infections and cancer.
-
Optimizing HIV Therapy for AIDS-Related Lymphoma Patients
This study tests whether long-acting HIV medicines given during lymphoma treatment work better at keeping the virus suppressed than standard oral therapy in adults with AIDS-related lymphoma.
-
Colchicine to see if it reduces coronary artery inflammation in people with HIV
This study tests whether low-dose colchicine can lower inflammation in the coronary arteries of people with HIV who are at high heart-disease risk, compared with a placebo.
-
Darunavir/ritonavir plus lamivudine vs darunavir/ritonavir plus tenofovir alafenamide/emtricitabine in virologically suppressed adults with HIV
This trial tests whether a two-drug regimen (darunavir/cobicistat plus lamivudine) works as well as a three-drug regimen (darunavir/cobicistat plus TAF/FTC) in adults with HIV who have stable viral suppression.
-
Dental care for people living with HIV in Pays de la Loire
This study looks at whether people living with HIV in Pays de la Loire need any special dental management based on their health data.
-
Cardiovascular health in children and young adults with chronic conditions
This project will see if children and young adults (ages 6-25) with chronic health conditions show early signs of aging in large and small blood vessels using noninvasive imaging and clinical tests.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.