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Completed

NCT Number: NCT01676974

Carriage Of Multiresistant Bacteria After Travel

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academisch Medisch Centrum, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. acquisition rate

    Time frame: 1 year

    the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel

Secondary outcomes

  1. duration of colonization

    Time frame: 1 year

  2. rate of secondary transmission within households

    Time frame: 1 year

  3. identification of risk factors

    Time frame: 1 year

  4. occurrence of self-reported infections in the year following travel

    Time frame: 1 year

  5. abundance and type of resistance

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Erasmus Medical Center
  • Maastricht University Medical Center
  • Utrecht University
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: COMBAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Aug 31, 2012
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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