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Carriage Of Multiresistant Bacteria After Travel

Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01676974
Acronym
COMBAT
Enrollment
2215
Registered
2012-08-31
Start date
2012-11-30
Completion date
2016-07-31
Last updated
2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterobacteriaceae, Infection

Keywords

Drug Resistance, Microbial, Enterobacteriaceae, ESBL, Carbapenemase, 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.

Interventions

None listed

Sponsors

Maastricht University Medical Center
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Utrecht University
CollaboratorOTHER
ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
acquisition rate1 yearthe acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel

Secondary

MeasureTime frame
duration of colonization1 year
rate of secondary transmission within households1 year
identification of risk factors1 year
occurrence of self-reported infections in the year following travel1 year
abundance and type of resistance1 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026