<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767374</url>
  </required_header>
  <id_info>
    <org_study_id>IMEA 52</org_study_id>
    <nct_id>NCT03767374</nct_id>
  </id_info>
  <brief_title>Risk-factors for Multidrug-resistant Bacteria Colonization Among Patients at High Risk of STIs</brief_title>
  <acronym>BMR-IST</acronym>
  <official_title>Risk-factors for Multidrug-resistant (MDR) and Extensively Drug-resistant (XDR) Bacteria Colonization Among Patients at High Risk of STIs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ANRS, Emerging Infectious Diseases</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to identify risk factors and prevalence of multidrug-resistant (MDR)&#xD;
      and extensively drug-resistant (XDR) bacteria colonization among patients at high risk of&#xD;
      STIs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The spread of multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria have&#xD;
      become a worldwide public health concern. Infection with MDR/XDR bacteria is associated with&#xD;
      increased morbidity, increased risk of therapeutic failure and healthcare costs. The largest&#xD;
      burden is from extended-spectrum betalactamase-producing enterobacteriaceae (ESBL) and&#xD;
      carbapenem-resistant enterobacteriaceae (CRE).&#xD;
&#xD;
      The World Health Organization (WHO) has considered the epidemic of MDR/XDR bacteria as a&#xD;
      major health concern and has registered these bacteria in the &quot;priory pathogens list.&quot; This&#xD;
      list includes pathogens for which new antibiotics are urgently needed. Moreover, in their&#xD;
      recent report on ESBL, the French National Authorities of Health (HAS) has recommended that&#xD;
      additional studies be conducted to improve knowledge about colonization risk factors.&#xD;
&#xD;
      Some risk factors have been already identified: antibiotic intake and travel to countries&#xD;
      with high MCR/XDR bacteria prevalence; however, many others are poorly identified. Patients&#xD;
      visiting the CeGIDD (free information, screening and diagnosis center for sexually&#xD;
      transmitted infections) and those receiving pre-exposure prophylaxis (PrEP) to prevent HIV&#xD;
      infection are more exposed to STIs (including methicillin-resistant staphylococcus aureus,&#xD;
      MRSA) and receive antibiotics for STI treatment. Moreover, an increase of STIs has been&#xD;
      recently observed in men who have sex with men and in patients receiving PrEP. As antibiotic&#xD;
      use is likely considerably increased in this population, we anticipate a high proportion with&#xD;
      MDR/XDR colonization.&#xD;
&#xD;
      The objective of the &quot;BMR-IST&quot; study is to identify risk-factors (i.e. sexual behaviors, HIV&#xD;
      status, antiretroviral PrEP, STIs, antibiotic use and travel to epidemic countries) of&#xD;
      MDR/XDR bacteria colonization among patients at high risk of acquiring STIs and to determine&#xD;
      the prevalence of MDR colonization in the studied population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 11, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of ESBL and/or CRE colonization</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of participants with ESBL and/or CRE colonization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Loss of ESBL and/or CRE colonization after 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STI prevalence</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of participants with an STIs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of ESBL and/or CRE colonization in the PrEP group</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of participants undergoing PrEP with ESBL and/or CRE colonization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure</measure>
    <time_frame>0 months</time_frame>
    <description>Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2186</enrollment>
  <condition>Bacterial Infections</condition>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Main study group (HIV-negative)</arm_group_label>
    <description>2000 HIV-negative individuals seeking care at the STI clinic of Saint-Antoine Hospital&#xD;
Inguinal swab sample&#xD;
Anal swab sample&#xD;
Fecal sample&#xD;
Risk factor assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exposure-matched group (HIV-positive)</arm_group_label>
    <description>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).&#xD;
Inguinal swab sample&#xD;
Anal swab sample&#xD;
Fecal sample&#xD;
Risk factor assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inguinal swab sample</intervention_name>
    <description>Inguinal samples using swab at cross-sectional visit</description>
    <arm_group_label>Exposure-matched group (HIV-positive)</arm_group_label>
    <arm_group_label>Main study group (HIV-negative)</arm_group_label>
    <other_name>ESwab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anal swab sample</intervention_name>
    <description>Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)</description>
    <arm_group_label>Exposure-matched group (HIV-positive)</arm_group_label>
    <arm_group_label>Main study group (HIV-negative)</arm_group_label>
    <other_name>ESwab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fecal sample</intervention_name>
    <description>Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)</description>
    <arm_group_label>Exposure-matched group (HIV-positive)</arm_group_label>
    <arm_group_label>Main study group (HIV-negative)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Risk factor assessment</intervention_name>
    <description>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</description>
    <arm_group_label>Exposure-matched group (HIV-positive)</arm_group_label>
    <arm_group_label>Main study group (HIV-negative)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Inguinal (at inclusion) and anal swab samples (at inclusion and after 6 months) Fecal sample&#xD;
      (at inclusion and after 6 months, only for patients identified with ESBL and/or CRE&#xD;
      colonization)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort 1: HIV-negative individuals at high risk of STI infection seeking care at a STI&#xD;
        testing center in Paris, France&#xD;
&#xD;
        Cohort 2: HIV-positive individuals seeking care at a university hospital in Paris, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cohort 1 -&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Consulting at the STI clinic of Saint-Antoine Hospital&#xD;
&#xD;
          -  Signed the informed consent form&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
        - No fluency in French&#xD;
&#xD;
        Cohort 2 -&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Men who have sex with men&#xD;
&#xD;
          -  Seeking care at Saint-Antoine Hospital&#xD;
&#xD;
          -  HIV-positive&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
        - No fluency in French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laure Surgers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint-Antoine Hospital, Paris, France 75012</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CeGIDD and Infections Diseases Unit</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
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    <citation>Coque TM, Baquero F, Canton R. Increasing prevalence of ESBL-producing Enterobacteriaceae in Europe. Euro Surveill. 2008 Nov 20;13(47):19044. Erratum In: Euro Surveill. 2008 Nov 27;13(48). pii: 19051.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>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.</citation>
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    <citation>Tumbarello M, Sanguinetti M, Montuori E, Trecarichi EM, Posteraro B, Fiori B, Citton R, D'Inzeo T, Fadda G, Cauda R, Spanu T. Predictors of mortality in patients with bloodstream infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: importance of inadequate initial antimicrobial treatment. Antimicrob Agents Chemother. 2007 Jun;51(6):1987-94. doi: 10.1128/AAC.01509-06. Epub 2007 Mar 26. Erratum In: Antimicrob Agents Chemother. 2007 Sep;51(9):3469.</citation>
    <PMID>17387156</PMID>
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    <citation>Woerther PL, Burdet C, Chachaty E, Andremont A. Trends in human fecal carriage of extended-spectrum beta-lactamases in the community: toward the globalization of CTX-M. Clin Microbiol Rev. 2013 Oct;26(4):744-58. doi: 10.1128/CMR.00023-13.</citation>
    <PMID>24092853</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 6, 2019</last_update_submitted>
  <last_update_submitted_qc>December 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MDR, XDR, ESBL, ESBL, MRSA, CRE</keyword>
  <keyword>HIV, PrEP, CeGIDD, STI, bacteria colonization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Will be decided later by the scientific committee at the end of the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767374
org study id: IMEA 52
nct id: NCT03767374
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of ESBL and/or CRE colonization
time frame: 0 months
description: Proportion of participants with ESBL and/or CRE colonization
measure: Loss of ESBL and/or CRE colonization after 6 months
time frame: 6 months
description: Proportion of ESBL and/or CRE colonized participants no longer colonized at 6 months
measure: STI prevalence
time frame: 0 months
description: Proportion of participants with an STIs
measure: Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group
time frame: 0 months
description: Proportion of HIV-negative MSM participants with ESBL and/or CRE colonization
measure: Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group
time frame: 0 months
description: Proportion of HIV-positive MSM participants with ESBL and/or CRE colonization
measure: Prevalence of ESBL and/or CRE colonization in the PrEP group
time frame: 0 months
description: Proportion of participants undergoing PrEP with ESBL and/or CRE colonization
measure: Prevalence of ESBL and/or CRE colonization in those with previous antibiotic exposure
time frame: 0 months
description: Proportion of participants having previous antibiotic exposure with ESBL and /or CRE colonization
arm group label: Main study group (HIV-negative)
description: 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
arm group label: Exposure-matched group (HIV-positive)
description: 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
intervention type: Procedure
intervention name: Inguinal swab sample
description: Inguinal samples using swab at cross-sectional visit
arm group label: Exposure-matched group (HIV-positive)
arm group label: Main study group (HIV-negative)
other name: ESwab
intervention type: Procedure
intervention name: Anal swab sample
description: Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
arm group label: Exposure-matched group (HIV-positive)
arm group label: Main study group (HIV-negative)
other name: ESwab
intervention type: Procedure
intervention name: Fecal sample
description: Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
arm group label: Exposure-matched group (HIV-positive)
arm group label: Main study group (HIV-negative)
intervention type: Other
intervention name: Risk factor assessment
description: 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
arm group label: Exposure-matched group (HIV-positive)
arm group label: Main study group (HIV-negative)
Inguinal (at inclusion) and anal swab samples (at inclusion and after 6 months) Fecal sample
      (at inclusion and after 6 months, only for patients identified with ESBL and/or CRE
      colonization)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laure Surgers, MD
role: Principal Investigator
affiliation: Saint-Antoine Hospital, Paris, France 75012
facility: 
country: France
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citation: 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.
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PMID: 23143897
citation: 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.
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citation: 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.
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citation: Schwaber MJ, Navon-Venezia S, Kaye KS, Ben-Ami R, Schwartz D, Carmeli Y. Clinical and economic impact of bacteremia with extended- spectrum-beta-lactamase-producing Enterobacteriaceae. Antimicrob Agents Chemother. 2006 Apr;50(4):1257-62. doi: 10.1128/AAC.50.4.1257-1262.2006.
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PMID: 19480576
citation: Tumbarello M, Sanguinetti M, Montuori E, Trecarichi EM, Posteraro B, Fiori B, Citton R, D'Inzeo T, Fadda G, Cauda R, Spanu T. Predictors of mortality in patients with bloodstream infections caused by extended-spectrum-beta-lactamase-producing Enterobacteriaceae: importance of inadequate initial antimicrobial treatment. Antimicrob Agents Chemother. 2007 Jun;51(6):1987-94. doi: 10.1128/AAC.01509-06. Epub 2007 Mar 26. Erratum In: Antimicrob Agents Chemother. 2007 Sep;51(9):3469.
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PMID: 24092853
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
sharing ipd: Undecided
ipd description: Will be decided later by the scientific committee at the end of the study.