Bacterial InfectionsBMR-ISTNCT03767374

Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs

An observational study of Bacterial Infections and HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bacterial Infections, HIV Infections
What is being tested?: Inguinal swab sample, Anal swab sample and Fecal sample
Type of treatment: Surgery or procedure
How many people: 2,186 participants
Where: 1 siteFrance
Study dates: 11 May 2018to 31 Dec 2020
Phase: Observational
Are there results?: None posted in the registry

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Cohort 1: HIV-negative individuals at high risk of STI infection seeking care at a STI testing center in Paris, France Cohort 2: HIV-positive individuals seeking care at a university hospital in Paris, France

Who may be able to join

Age ≥ 18 years
Consulting at the STI clinic of Saint-Antoine Hospital
Signed the informed consent form
Non-inclusion criteria:
No fluency in French
Cohort 2 -

Show all 11Show fewer

Men who have sex with men
Seeking care at Saint-Antoine Hospital
HIV-positive
Non-inclusion criteria:
No fluency in French

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

CeGIDD and Infections Diseases Unit
Paris, 75012

Other trials in France

About this study

Official title: Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs

The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs

Read the detailed description

The spread of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria have become a worldwide public health concern. Infection with MDR/XDR bacteria is associated with increased morbidity, increased risk of therapeutic failure and healthcare costs. The largest burden is from extended-spectrum betalactamase-producing enterobacteriaceae (ESBL) and carbapenem-resistant enterobacteriaceae (CRE).

The World Health Organization (WHO) has considered the epidemic of MDR/XDR bacteria as a major health concern and has registered these bacteria in the "priory pathogens list." This list includes pathogens for which new antibiotics are urgently needed. Moreover, in their recent report on ESBL, the French National Authorities of Health (HAS) has recommended that additional studies be conducted to improve knowledge about colonization risk factors.

Some risk factors have been already identified: antibiotic intake and travel to countries with high MCR/XDR bacteria prevalence; however, many others are poorly identified. Patients visiting the CeGIDD (free information, screening and diagnosis center for sexually transmitted infections) and those receiving pre-exposure prophylaxis (PrEP) to prevent HIV infection are more exposed to STIs (including methicillin-resistant staphylococcus aureus, MRSA) and receive antibiotics for STI treatment. Moreover, an increase of STIs has been recently observed in men who have sex with men and in patients receiving PrEP. As antibiotic use is likely considerably increased in this population, we anticipate a high proportion with MDR/XDR colonization.

The objective of the "BMR-IST" study is to identify risk-factors (i.e. sexual behaviors, HIV status, antiretroviral PrEP, STIs, antibiotic use and travel to epidemic countries) of MDR/XDR bacteria colonization among patients at high risk of acquiring STIs and to determine the prevalence of MDR colonization in the studied population.

Conditions: Bacterial Infections, HIV Infections
Being tested: Inguinal swab sample, Anal swab sample, Fecal sample, Risk factor assessment
Keywords: MDR, XDR, ESBL, ESBL, MRSA, CRE, HIV, PrEP, CeGIDD, STI, bacteria colonization
Medical subject headings: Bacterial Infections, HIV Infections, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inguinal swab sampleProcedure or surgery
Also called ESwab
Inguinal samples using swab at cross-sectional visit
Anal swab sampleProcedure or surgery
Also called ESwab
Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Fecal sampleProcedure or surgery
Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
Risk factor assessmentOther
Patients will be asked questions on risk factors associated with MDR/XDR colonization at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization

Study groups in NCT03767374
Study group	Role	What they receive
Main study group (HIV-negative)		2000 HIV-negative individuals seeking care at the STI clinic of Saint-Antoine Hospital * Inguinal swab sample * Anal swab sample * Fecal sample * Risk factor assessment Receives: Procedure: Inguinal swab sample; Procedure: Anal swab sample; Procedure: Fecal sample; Other: Risk factor assessment
Exposure-matched group (HIV-positive)		500 HIV-positive men who have sex with men from the Infectious Diseases Unit of Saint- Antoine Hospital. These individuals will be compared to 500 HIV-negative MSM from the main study group, matching on age (+/-5 years). * Inguinal swab sample * Anal swab sample * Fecal sample * Risk factor assessment Receives: Procedure: Inguinal swab sample; Procedure: Anal swab sample; Procedure: Fecal sample; Other: Risk factor assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of ESBL and/or CRE colonization
Proportion of participants with ESBL and/or CRE colonization
Measured: 0 months

Secondary outcomes (6)

Loss of ESBL and/or CRE colonization after 6 months
Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months
Measured: 6 months
STI prevalence
Proportion of participants with an STIs
Measured: 0 months
Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group
Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization
Measured: 0 months
Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group
Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization
Measured: 0 months
Prevalence of ESBL and/or CRE colonization in the PrEP group
Proportion of participants undergoing PrEP with ESBL and/or CRE colonization
Measured: 0 months
Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure
Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization
Measured: 0 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 201831 Dec 2020

First posted6 Dec 2018
Study start11 May 2018
Primary completion30 Jun 2019
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
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: Cohort
Time perspective: Cross-sectional
Enrolment: 2,186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03767374
Sponsor's protocol ID: IMEA 52
Acronym: BMR-IST
Status last verified: Oct 2022
First submitted: 5 Dec 2018
Last updated: 4 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Will be decided later by the scientific committee at the end of the study.

Publications

Ben-Ami R, Rodriguez-Bano J, Arslan H, Pitout JD, Quentin C, Calbo ES, Azap OK, Arpin C, Pascual A, Livermore DM, Garau J, Carmeli Y. A multinational survey of risk factors for infection with extended-spectrum beta-lactamase-producing enterobacteriaceae in nonhospitalized patients. Clin Infect Dis. 2009 Sep 1;49(5):682-90. doi: 10.1086/604713.
PubMed 19622043
Canton R, Coque TM. The CTX-M beta-lactamase pandemic. Curr Opin Microbiol. 2006 Oct;9(5):466-75. doi: 10.1016/j.mib.2006.08.011. Epub 2006 Aug 30.
PubMed 16942899
Coque TM, Baquero F, Canton R. Increasing prevalence of ESBL-producing Enterobacteriaceae in Europe. Euro Surveill. 2008 Nov 20;13(47):19044.
PubMed 19021958
Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008 Feb 19;148(4):249-57. doi: 10.7326/0003-4819-148-4-200802190-00204. Epub 2008 Jan 30.
PubMed 18283202
Gaudreau C, Pilon PA, Sylvestre JL, Boucher F, Bekal S. Multidrug-Resistant Campylobacter coli in Men Who Have Sex with Men, Quebec, Canada, 2015. Emerg Infect Dis. 2016 Sep;22(9):1661-3. doi: 10.3201/eid2209.151695. No abstract available.
PubMed 27533504
Harris AD, McGregor JC, Johnson JA, Strauss SM, Moore AC, Standiford HC, Hebden JN, Morris JG Jr. Risk factors for colonization with extended-spectrum beta-lactamase-producing bacteria and intensive care unit admission. Emerg Infect Dis. 2007 Aug;13(8):1144-9. doi: 10.3201/eid1308.070071.
PubMed 17953083
Jean SS, Lee WS, Lam C, Hsu CW, Chen RJ, Hsueh PR. Carbapenemase-producing Gram-negative bacteria: current epidemics, antimicrobial susceptibility and treatment options. Future Microbiol. 2015;10(3):407-25. doi: 10.2217/fmb.14.135.
PubMed 25812463
Livermore DM, Canton R, Gniadkowski M, Nordmann P, Rossolini GM, Arlet G, Ayala J, Coque TM, Kern-Zdanowicz I, Luzzaro F, Poirel L, Woodford N. CTX-M: changing the face of ESBLs in Europe. J Antimicrob Chemother. 2007 Feb;59(2):165-74. doi: 10.1093/jac/dkl483. Epub 2006 Dec 6.
PubMed 17158117
Livermore DM. Has the era of untreatable infections arrived? J Antimicrob Chemother. 2009 Sep;64 Suppl 1:i29-36. doi: 10.1093/jac/dkp255.
PubMed 19675016
Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
PubMed 26624850
Landry MM, Sarma DP. In-situ chondrosarcoma of the foot arising in a solitary enchondroma. J Foot Surg. 1990 Jul-Aug;29(4):324-6.
PubMed 2229904
Nicolas-Chanoine MH, Gruson C, Bialek-Davenet S, Bertrand X, Thomas-Jean F, Bert F, Moyat M, Meiller E, Marcon E, Danchin N, Noussair L, Moreau R, Leflon-Guibout V. 10-Fold increase (2006-11) in the rate of healthy subjects with extended-spectrum beta-lactamase-producing Escherichia coli faecal carriage in a Parisian check-up centre. J Antimicrob Chemother. 2013 Mar;68(3):562-8. doi: 10.1093/jac/dks429. Epub 2012 Nov 9.
PubMed 23143897
Osthoff M, McGuinness SL, Wagen AZ, Eisen DP. Urinary tract infections due to extended-spectrum beta-lactamase-producing Gram-negative bacteria: identification of risk factors and outcome predictors in an Australian tertiary referral hospital. Int J Infect Dis. 2015 May;34:79-83. doi: 10.1016/j.ijid.2015.03.006. Epub 2015 Mar 11.
PubMed 25769526
Rodriguez-Bano J, Lopez-Cerero L, Navarro MD, Diaz de Alba P, Pascual A. Faecal carriage of extended-spectrum beta-lactamase-producing Escherichia coli: prevalence, risk factors and molecular epidemiology. J Antimicrob Chemother. 2008 Nov;62(5):1142-9. doi: 10.1093/jac/dkn293. Epub 2008 Jul 18.
PubMed 18641033
Ruppe E, Lixandru B, Cojocaru R, Buke C, Paramythiotou E, Angebault C, Visseaux C, Djuikoue I, Erdem E, Burduniuc O, El Mniai A, Marcel C, Perrier M, Kesteman T, Clermont O, Denamur E, Armand-Lefevre L, Andremont A. Relative fecal abundance of extended-spectrum-beta-lactamase-producing Escherichia coli strains and their occurrence in urinary tract infections in women. Antimicrob Agents Chemother. 2013 Sep;57(9):4512-7. doi: 10.1128/AAC.00238-13. Epub 2013 Jul 8.
PubMed 23836184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs
ClinicalTrials.gov ID: NCT03767374
Acronym / sponsor ID: BMR-IST / IMEA 52
Conditions: Bacterial Infections, HIV Infections
Keywords: MDR, XDR, ESBL, ESBL, MRSA, CRE, HIV, PrEP, CeGIDD, STI, bacteria colonization
Study type: Observational
Recruitment status: Completed
Enrolment: 2,186 participants (actual)
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
Collaborators: ANRS, Emerging Infectious Diseases
Study start: 11 May 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 6 Dec 2018 (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 aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of STIs

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Main study group (HIV-negative)	–	Procedure: Inguinal swab sample, Procedure: Anal swab sample, Procedure: Fecal sample, Other: Risk factor assessment2000 HIV-negative individuals seeking care at the STI clinic of Saint-Antoine Hospital * Inguinal swab sample * Anal swab sample * Fecal sample * Risk factor assessment
Exposure-matched group (HIV-positive)	–	Procedure: Inguinal swab sample, Procedure: Anal swab sample, Procedure: Fecal sample, Other: Risk factor assessment500 HIV-positive men who have sex with men from the Infectious Diseases Unit of Saint- Antoine Hospital. These individuals will be compared to 500 HIV-negative MSM from the main study group, matching on age (+/-5 years). * Inguinal swab sample * Anal swab sample * Fecal sample * Risk factor assessment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Cohort 1: HIV-negative individuals at high risk of STI infection seeking care at a STI testing center in Paris, France Cohort 2: HIV-positive individuals seeking care at a university hospital in Paris, France

Key inclusion criteria (11 listed)

Age ≥ 18 years
Consulting at the STI clinic of Saint-Antoine Hospital
Signed the informed consent form
No fluency in French
Cohort 2 -

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inguinal swab sampleAlso: ESwabInguinal samples using swab at cross-sectional visit	Procedure or surgery	Exposure-matched group (HIV-positive), Main study group (HIV-negative)
Anal swab sampleAlso: ESwabAnal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)	Procedure or surgery	Exposure-matched group (HIV-positive), Main study group (HIV-negative)
Fecal sampleFecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)	Procedure or surgery	Exposure-matched group (HIV-positive), Main study group (HIV-negative)
Risk factor assessmentPatients will be asked questions on risk factors associated with MDR/XDR colonization at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization	Other	Exposure-matched group (HIV-positive), Main study group (HIV-negative)

Primary outcome

Prevalence of ESBL and/or CRE colonization
Time frame: 0 months
Proportion of participants with ESBL and/or CRE colonization

6 secondary outcomes

Loss of ESBL and/or CRE colonization after 6 months
Time frame: 6 months
STI prevalence
Time frame: 0 months
Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group
Time frame: 0 months
Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group
Time frame: 0 months
Prevalence of ESBL and/or CRE colonization in the PrEP group
Time frame: 0 months
Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure
Time frame: 0 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Background: PubMed 19622043Ben-Ami R, Rodriguez-Bano J, Arslan H, Pitout JD, Quentin C, Calbo ES, Azap OK, Arpin C, Pascual A, Livermore DM, Garau J, Carmeli Y. A multinational survey of risk factors for infection with extended-spectrum beta-lactamase-producing enterobacteriaceae in nonhospitalized patients. Clin Infect Dis. 2009 Sep 1;49(5):682-90. doi: 10.1086/604713.
Background: PubMed 16942899Canton R, Coque TM. The CTX-M beta-lactamase pandemic. Curr Opin Microbiol. 2006 Oct;9(5):466-75. doi: 10.1016/j.mib.2006.08.011. Epub 2006 Aug 30.
Background: PubMed 19021958Coque TM, Baquero F, Canton R. Increasing prevalence of ESBL-producing Enterobacteriaceae in Europe. Euro Surveill. 2008 Nov 20;13(47):19044.
Background: PubMed 18283202Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008 Feb 19;148(4):249-57. doi: 10.7326/0003-4819-148-4-200802190-00204. Epub 2008 Jan 30.
Background: PubMed 27533504Gaudreau C, Pilon PA, Sylvestre JL, Boucher F, Bekal S. Multidrug-Resistant Campylobacter coli in Men Who Have Sex with Men, Quebec, Canada, 2015. Emerg Infect Dis. 2016 Sep;22(9):1661-3. doi: 10.3201/eid2209.151695. No abstract available.
Background: PubMed 17953083Harris AD, McGregor JC, Johnson JA, Strauss SM, Moore AC, Standiford HC, Hebden JN, Morris JG Jr. Risk factors for colonization with extended-spectrum beta-lactamase-producing bacteria and intensive care unit admission. Emerg Infect Dis. 2007 Aug;13(8):1144-9. doi: 10.3201/eid1308.070071.
Background: PubMed 25812463Jean SS, Lee WS, Lam C, Hsu CW, Chen RJ, Hsueh PR. Carbapenemase-producing Gram-negative bacteria: current epidemics, antimicrobial susceptibility and treatment options. Future Microbiol. 2015;10(3):407-25. doi: 10.2217/fmb.14.135.
Background: PubMed 17158117Livermore DM, Canton R, Gniadkowski M, Nordmann P, Rossolini GM, Arlet G, Ayala J, Coque TM, Kern-Zdanowicz I, Luzzaro F, Poirel L, Woodford N. CTX-M: changing the face of ESBLs in Europe. J Antimicrob Chemother. 2007 Feb;59(2):165-74. doi: 10.1093/jac/dkl483. Epub 2006 Dec 6.
Background: PubMed 19675016Livermore DM. Has the era of untreatable infections arrived? J Antimicrob Chemother. 2009 Sep;64 Suppl 1:i29-36. doi: 10.1093/jac/dkp255.
Background: PubMed 26624850Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
Background: PubMed 2229904Landry MM, Sarma DP. In-situ chondrosarcoma of the foot arising in a solitary enchondroma. J Foot Surg. 1990 Jul-Aug;29(4):324-6.
Background: PubMed 23143897Nicolas-Chanoine MH, Gruson C, Bialek-Davenet S, Bertrand X, Thomas-Jean F, Bert F, Moyat M, Meiller E, Marcon E, Danchin N, Noussair L, Moreau R, Leflon-Guibout V. 10-Fold increase (2006-11) in the rate of healthy subjects with extended-spectrum beta-lactamase-producing Escherichia coli faecal carriage in a Parisian check-up centre. J Antimicrob Chemother. 2013 Mar;68(3):562-8. doi: 10.1093/jac/dks429. Epub 2012 Nov 9.
Individual participant dataSharing planned: Undecided. Will be decided later by the scientific committee at the end of the study.

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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. This study is not recruiting at the moment.

Laure Surgers, MD principal investigator

Saint-Antoine Hospital, Paris, France 75012

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 Bacterial Infections and HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 1 site in France.

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 11 inclusion and 0 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: finished, as of the sponsor's last update on 4 Oct 2024. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of ESBL and/or CRE colonization (time frame: 0 months). 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 NCT03767374, which also lists 19 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 4 Oct 2024.