Enterobacteriaceae, Infection Clinical Trial
Official title:
Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands
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.
Rationale: Antimicrobial resistance (AMR) among Enterobacteriaceae constitutes an
increasingly important human health hazard worldwide. Also in the Netherlands AMR rates have
been on the rise in recent years. A limited number of previous studies have suggested high
acquisition rates of AMR E. coli during international travel, but information on
travel-associated risk factors, duration of colonization and local transmission of imported
AMR are largely, if not entirely, lacking.
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.
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Observational Model: Ecologic or Community, Time Perspective: Prospective