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

NCT03767374 | Completed DMC

• 1 other identifier: IMEA 52
• Study Type: observational
• Target: 2,186
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bacterial Infections; HIV Infections

Keywords

MDR, XDR, ESBL, ESBL, MRSA, CRE; HIV, PrEP, CeGIDD, STI, bacteria colonization

Outcome Measures

Primary Outcomes (1)

• Prevalence of ESBL and/or CRE colonization

  Proportion of participants with ESBL and/or CRE colonization

  0 months

Secondary Outcomes (6)

• Loss of ESBL and/or CRE colonization after 6 months

  6 months

• STI prevalence

  0 months

• Prevalence of ESBL and/or CRE colonization in the HIV-negative MSM group

  0 months

• Prevalence of ESBL and/or CRE colonization in the HIV-positive MSM group

  0 months

• Prevalence of ESBL and/or CRE colonization in the PrEP group

  0 months

Study Arms (2)

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

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

Procedure: Inguinal swab sample; Procedure: Anal swab sample; Procedure: Fecal sample; Other: Risk factor assessment

Interventions

Inguinal swab sample PROCEDURE

Inguinal samples using swab at cross-sectional visit

Also known as: ESwab

Exposure-matched group (HIV-positive); Main study group (HIV-negative)

Anal swab sample PROCEDURE

Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)

Also known as: ESwab

Exposure-matched group (HIV-positive); Main study group (HIV-negative)

Fecal sample PROCEDURE

Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)

Exposure-matched group (HIV-positive); Main study group (HIV-negative)

Risk factor assessment OTHER

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

Exposure-matched group (HIV-positive); Main study group (HIV-negative)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Age ≥ 18 years
• Consulting at the STI clinic of Saint-Antoine Hospital
• Signed the informed consent form
• \- No fluency in French
• Cohort 2 -
• Men who have sex with men
• Seeking care at Saint-Antoine Hospital
• HIV-positive
• \- No fluency in French

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (1)

CeGIDD and Infections Diseases Unit

Paris, 75012, France

Location

Related Publications (19)

• 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.

  PMID: 19622043 BACKGROUND

• 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.

  PMID: 16942899 BACKGROUND

• Coque TM, Baquero F, Canton R. Increasing prevalence of ESBL-producing Enterobacteriaceae in Europe. Euro Surveill. 2008 Nov 20;13(47):19044.

  PMID: 19021958 BACKGROUND

• 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.

  PMID: 18283202 BACKGROUND

• 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.

  PMID: 27533504 BACKGROUND

• 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.

  PMID: 17953083 BACKGROUND

• 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.

  PMID: 25812463 BACKGROUND

• 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.

  PMID: 17158117 BACKGROUND

• Livermore DM. Has the era of untreatable infections arrived? J Antimicrob Chemother. 2009 Sep;64 Suppl 1:i29-36. doi: 10.1093/jac/dkp255.

  PMID: 19675016 BACKGROUND

• 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.

  PMID: 26624850 BACKGROUND

• 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.

  PMID: 2229904 BACKGROUND

• 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.

  PMID: 23143897 BACKGROUND

• 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.

  PMID: 25769526 BACKGROUND

• 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.

  PMID: 18641033 BACKGROUND

• 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.

  PMID: 23836184 BACKGROUND

• 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.

  PMID: 16569837 BACKGROUND

• Szumowski JD, Wener KM, Gold HS, Wong M, Venkataraman L, Runde CA, Cohen DE, Mayer KH, Wright SB. Methicillin-resistant Staphylococcus aureus colonization, behavioral risk factors, and skin and soft-tissue infection at an ambulatory clinic serving a large population of HIV-infected men who have sex with men. Clin Infect Dis. 2009 Jul 1;49(1):118-21. doi: 10.1086/599608.

  PMID: 19480576 BACKGROUND

• 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.

  PMID: 17387156 BACKGROUND

• 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.

  PMID: 24092853 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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)

MeSH Terms

Conditions

Bacterial Infections; HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laure Surgers, MD

  Saint-Antoine Hospital, Paris, France 75012

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: May 11, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2020
• Last Updated: October 4, 2024

Record last verified: 2022-10

Locations

FR (1)