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

NCT07370948 | Recruiting

• 1 other identifier: ENTERO-PrEP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection

Outcome Measures

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/).

  At enrolment

Secondary Outcomes (1)

• Prevalence of antibiotic-resistant Enterobacterales strains

  At enrolment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Related Publications (15)

• Williams ADN, Wood F, Gillespie D, Couzens Z, Hughes K, Hood K. The relationship between HIV pre-exposure prophylaxis, sexually transmitted infections, and antimicrobial resistance: a qualitative interview study of men who have sex with men. BMC Public Health. 2022 Nov 29;22(1):2222. doi: 10.1186/s12889-022-14645-0.

  PMID: 36447181 BACKGROUND

• Van Dijck C, Laumen JGE, de Block T, Abdellati S, De Baetselier I, Tsoumanis A, Malhotra-Kumar S, Manoharan-Basil SS, Kenyon C, Xavier BB. The oropharynx of men using HIV pre-exposure prophylaxis is enriched with antibiotic resistance genes: A cross-sectional observational metagenomic study. J Infect. 2023 Apr;86(4):329-337. doi: 10.1016/j.jinf.2023.02.006. Epub 2023 Feb 9.

  PMID: 36764395 BACKGROUND

• Vanbaelen T, Van Dijck C, De Baetselier I, Florence E, Reyniers T, Vuylsteke B, Jacobs BK, Kenyon C. Screening for STIs is one of the main drivers of macrolide consumption in PrEP users. Int J STD AIDS. 2021 Oct;32(12):1183-1184. doi: 10.1177/09564624211025940. Epub 2021 Jun 17. No abstract available.

  PMID: 34139924 BACKGROUND

• Traeger MW, Schroeder SE, Wright EJ, Hellard ME, Cornelisse VJ, Doyle JS, Stoove MA. Effects of Pre-exposure Prophylaxis for the Prevention of Human Immunodeficiency Virus Infection on Sexual Risk Behavior in Men Who Have Sex With Men: A Systematic Review and Meta-analysis. Clin Infect Dis. 2018 Aug 16;67(5):676-686. doi: 10.1093/cid/ciy182.

  PMID: 29509889 BACKGROUND

• Quaife M, MacGregor L, Ong JJ, Gafos M, Torres-Rueda S, Grant H, Terris-Prestholt F, Vickerman P. Risk compensation and STI incidence in PrEP programmes. Lancet HIV. 2020 Apr;7(4):e222-e223. doi: 10.1016/S2352-3018(19)30333-9. Epub 2019 Nov 22. No abstract available.

  PMID: 31767536 BACKGROUND

• Perez-Galera S, Bravo-Ferrer JM, Paniagua M, Kostyanev T, de Kraker MEA, Feifel J, Sojo-Dorado J, Schotsman J, Canton R, Daikos GL, Carevic B, Dragovac G, Tan LK, Raka L, Hristea A, Viale P, Akova M, Reguera JM, Valiente de Santis L, Torre-Cisneros J, Cano A, Roilides E, Radulovic L, Kirakli C, Shaw E, Falagas ME, Pintado V, Goossens H, Bonten MJ, Gutierrez-Gutierrez B, Rodriguez-Bano J; COMBACTE-CARE-EURECA Team. Risk factors for infections caused by carbapenem-resistant Enterobacterales: an international matched case-control-control study (EURECA). EClinicalMedicine. 2023 Feb 27;57:101871. doi: 10.1016/j.eclinm.2023.101871. eCollection 2023 Mar.

  PMID: 36895801 BACKGROUND

• Ong JJ, Baggaley RC, Wi TE, Tucker JD, Fu H, Smith MK, Rafael S, Anglade V, Falconer J, Ofori-Asenso R, Terris-Prestholt F, Hodges-Mameletzis I, Mayaud P. Global Epidemiologic Characteristics of Sexually Transmitted Infections Among Individuals Using Preexposure Prophylaxis for the Prevention of HIV Infection: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Dec 2;2(12):e1917134. doi: 10.1001/jamanetworkopen.2019.17134.

  PMID: 31825501 BACKGROUND

• Mogaka FO, Stewart J, Omollo V, Bukusi E. Challenges and Solutions to STI Control in the Era of HIV and STI Prophylaxis. Curr HIV/AIDS Rep. 2023 Oct;20(5):312-319. doi: 10.1007/s11904-023-00666-w. Epub 2023 Sep 26.

  PMID: 37751130 BACKGROUND

• Miller WR, Arias CA. ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics. Nat Rev Microbiol. 2024 Oct;22(10):598-616. doi: 10.1038/s41579-024-01054-w. Epub 2024 Jun 3.

  PMID: 38831030 BACKGROUND

• McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016 Jan 2;387(10013):53-60. doi: 10.1016/S0140-6736(15)00056-2. Epub 2015 Sep 9.

  PMID: 26364263 BACKGROUND

• Li H, Liu B, Li M, Shen M. Livestock and poultry breeding farms as a fixed and underestimated source of antibiotic resistance genes. Environ Sci Pollut Res Int. 2024 Aug;31(37):49916-49931. doi: 10.1007/s11356-024-34413-4. Epub 2024 Jul 25.

  PMID: 39052112 BACKGROUND

• Laumen JGE, Van Dijck C, Abdellati S, De Baetselier I, Serrano G, Manoharan-Basil SS, Bottieau E, Martiny D, Kenyon C. Antimicrobial susceptibility of commensal Neisseria in a general population and men who have sex with men in Belgium. Sci Rep. 2022 Jan 7;12(1):9. doi: 10.1038/s41598-021-03995-1.

  PMID: 34997050 BACKGROUND

• Kenyon C. Dual Azithromycin/Ceftriaxone Therapy for Gonorrhea in PrEP Cohorts Results in Levels of Macrolide Consumption That Exceed Resistance Thresholds by up to 7-Fold. J Infect Dis. 2021 Nov 16;224(9):1623-1624. doi: 10.1093/infdis/jiab178. No abstract available.

  PMID: 33822092 BACKGROUND

• Huang KD, Amend L, Galvez EJC, Lesker TR, de Oliveira R, Bielecka A, Blanco-Miguez A, Valles-Colomer M, Ruf I, Pasolli E, Buer J, Segata N, Esser S, Strowig T, Kehrmann J. Establishment of a non-Westernized gut microbiota in men who have sex with men is associated with sexual practices. Cell Rep Med. 2024 Mar 19;5(3):101426. doi: 10.1016/j.xcrm.2024.101426. Epub 2024 Feb 15.

  PMID: 38366600 BACKGROUND

• Cai S, Wang Z, Han X, Hu H, Quan J, Jiang Y, Du X, Zhou Z, Yu Y. The correlation between intestinal colonization and infection of carbapenem-resistant Klebsiella pneumoniae: A systematic review. J Glob Antimicrob Resist. 2024 Sep;38:187-193. doi: 10.1016/j.jgar.2024.04.013. Epub 2024 May 21.

  PMID: 38777180 BACKGROUND

MeSH Terms

Conditions

Infections

Central Study Contacts

Claudio Foschi, MD

CONTACT

+39 0512144515; claudio.foschi2@unibo.it

Leonardo Calza, MD

CONTACT

leonardo.calza@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 27, 2026
• Study Start: May 30, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 28, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)