Clinical trial NCT01676974: Carriage Of Multiresistant Bacteria After Travel
Official title: Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae, Infection
Keywords: Drug Resistance, Microbial
Enterobacteriaceae
ESBL
Carbapenemase
Travel
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Erasmus Medical Center
name: Utrecht University
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2012-08-31
Enrollment: 2215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Travelers and their family members not planning to travel

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* travelling for \> 1 week (7 days) AND \< 3 months (90 days)
* non traveling household members of these traveling volunteers

Primary outcomes:
measure: acquisition rate
timeFrame: 1 year
Secondary outcomes:
measure: duration of colonization
timeFrame: 1 year
measure: rate of secondary transmission within households
timeFrame: 1 year
measure: identification of risk factors
timeFrame: 1 year
measure: occurrence of self-reported infections in the year following travel
timeFrame: 1 year
measure: abundance and type of resistance
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Menno D. de Jong, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.