Study Results
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Basic Information
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COMPLETED
2215 participants
OBSERVATIONAL
2012-11-30
2016-07-31
Brief Summary
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Detailed Description
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Objectives: Prospectively study the influence of foreign travel and associated risk factors on the acquisition of AMR in the endogenous microbiota of healthy individuals and the subsequent persistence of AMR carriage and transmission to household members of these carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of bacterial infections in the year after travel (compared to non-carriers). Explore the full width of AMR genes and transferable genetic elements acquired during international travel.
Study design: multicenter longitudinal cohort study.
Study population: healthy, adult (\> 18 years) volunteers travelling abroad for 1 week - 3 months. Non travelling household members of these traveling volunteers.
Methods: Travelers and non-traveling household members will be recruited at outpatient travel clinics throughout The Netherlands. Faecal samples and questionnaires will be taken before (t=0) travel, immediately after travel (t=1) and 1 month upon return (t = 2). For volunteers that acquire AMR Enterobacteriaceae, repeated questionnaires and faecal samples will be taken after 3, 6 and 12 months.
Faecal samples will be cultured to screen for AMR Enterobacteriaceae. Suspected colonies will be identified and susceptibilities confirmed by standard methods. Genotypic characterization of the extended-spectrum betalactamase- (ESBL-) and carbapenemase genes will be performed using microarray and gene sequencing. Clonal bacterial spread within households will be confirmed or excluded by molecular typing.
Outcomes: The main outcome measure is the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel.
Secondary outcomes are the duration of colonization, the rate of secondary transmission within households, the identification of risk factors, occurrence of self-reported infections in the year following travel and the abundance and type of resistance.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Travelers
Travelers and their family members
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* travelling for \> 1 week (7 days) AND \< 3 months (90 days)
* non traveling household members of these traveling volunteers
18 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Erasmus Medical Center
OTHER
Utrecht University
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Menno D. de Jong, MD
Prof. dr. M.D. de Jong
Principal Investigators
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Menno D. de Jong, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academisch Medisch Centrum
Amsterdam, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Countries
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References
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Arcilla MS, van Hattem JM, Haverkate MR, Bootsma MCJ, van Genderen PJJ, Goorhuis A, Grobusch MP, Lashof AMO, Molhoek N, Schultsz C, Stobberingh EE, Verbrugh HA, de Jong MD, Melles DC, Penders J. Import and spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae by international travellers (COMBAT study): a prospective, multicentre cohort study. Lancet Infect Dis. 2017 Jan;17(1):78-85. doi: 10.1016/S1473-3099(16)30319-X. Epub 2016 Oct 14.
Arcilla MS, van Hattem JM, Bootsma MC, van Genderen PJ, Goorhuis A, Schultsz C, Stobberingh EE, Verbrugh HA, de Jong MD, Melles DC, Penders J. The Carriage Of Multiresistant Bacteria After Travel (COMBAT) prospective cohort study: methodology and design. BMC Public Health. 2014 Apr 28;14:410. doi: 10.1186/1471-2458-14-410.
Other Identifiers
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COMBAT
Identifier Type: -
Identifier Source: org_study_id
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