InfectionNCT07370948
Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects
An observational study of Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infection
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leonardo Calza, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Claudio Foschi, MD, +39 0512144515, claudio.foschi2@unibo.it
Leonardo Calza, MD, leonardo.calza@unibo.it
About this study
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.
Read the 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.
- Conditions
- Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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/).
Measured: At enrolment
Secondary 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/).
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start30 May 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370948
- Sponsor's protocol ID
- ENTERO-PrEP
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36447181Van 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.
PubMed 36764395Vanbaelen 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.
PubMed 34139924Traeger 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.
PubMed 29509889Quaife 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.
PubMed 31767536Perez-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.
PubMed 36895801Ong 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.
PubMed 31825501Mogaka 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.
PubMed 37751130Miller 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.
PubMed 38831030McCormack 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.
PubMed 26364263Li 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.
PubMed 39052112Laumen 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.
PubMed 34997050Kenyon 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.
PubMed 33822092Huang 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.
PubMed 38366600Cai 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.
PubMed 38777180
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Antibiotic-resistance Profile of Enterobacterales Isolated From Rectal Mucosal Buffer of PrEP Subjects
- ClinicalTrials.gov ID
- NCT07370948
- Acronym / sponsor ID
- ENTERO-PrEP
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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/).
1 secondary outcome
Prevalence of antibiotic-resistant Enterobacterales strains
Time frame: At enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 36447181Williams 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.
- Background: PubMed 36764395Van 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.
- Background: PubMed 34139924Vanbaelen 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.
- Background: PubMed 29509889Traeger 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.
- Background: PubMed 31767536Quaife 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.
- Background: PubMed 36895801Perez-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.
- Background: PubMed 31825501Ong 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.
- Background: PubMed 37751130Mogaka 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.
- Background: PubMed 38831030Miller 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.
- Background: PubMed 26364263McCormack 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.
- Background: PubMed 39052112Li 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.
- Background: PubMed 34997050Laumen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo Calza, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Foschi, MD (+39 0512144515, claudio.foschi2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of antibiotic-resistant Enterobacterales strains (time frame: At enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370948, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.