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

January 22, 2026 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

ENTERO-PrEP is an observational, single-center, cross-sectional, tissue study. Patient enrollment will be performed at dedicated clinics for the monitoring and follow-up of PrEP subjects at the Infectious Diseases Unit of the IRCCS - University Hospital of Bologna.

In these clinics, on a quarterly basis, PrEP subjects undergo, as a normal diagnostic-assistance path, laboratory tests to exclude the presence of STIs, including the search for Chlamydia trachomatis and Neisseria gonorrhoeae in genital (urine) and extra-genital samples (pharyngeal swab and anorectal swab).

Each patient will be recruited only once during one of the normal monitoring visits scheduled for subjects using PReP.

The study aims to isolate commensal Enterobacterales strains from the gastrointestinal tract starting from the same anorectal swab sent for the detection of C. trachomatis and N. gonorrhoeae, without the need to perform any additional sampling compared to the normal care routine. For each isolated Enterobacterales strain, the sensitivity/resistance to antimicrobials (antibiogram) will subsequently be studied using broth micro-dilution. Bacterial isolation and antibiogram will be performed at the Microbiology Unit of the IRCCS - University Hospital of Bologna.

Subjects who consent to participate in the study will be asked to complete, directly during the outpatient visit, a questionnaire with information relating to personal and behavioral habits in order to identify risk factors that could favor the presence of antibiotic-resistant Enterobacterales.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
male and female subjects aged between 18 and 45 years who use PrEP
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 follow-up visits 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of antibiotic-resistant Enterobacterales strains
Time Frame: 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/).
At enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of antibiotic-resistant Enterobacterales strains
Time Frame: 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/).
At enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENTERO-PrEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe