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Carriage Of Multiresistant Bacteria After Travel (COMBAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Maastricht University Medical Center
Erasmus Medical Center
Utrecht University
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Menno D. de Jong, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01676974
First received: August 29, 2012
Last updated: January 14, 2014
Last verified: January 2014

August 29, 2012
January 14, 2014
November 2012
November 2013   (final data collection date for primary outcome measure)
acquisition rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel
Same as current
Complete list of historical versions of study NCT01676974 on ClinicalTrials.gov Archive Site
  • duration of colonization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • rate of secondary transmission within households [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • identification of risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • occurrence of self-reported infections in the year following travel [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • abundance and type of resistance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Carriage Of Multiresistant Bacteria After Travel
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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Fecal Swab

Probability Sample

Travelers and their family members not planning to travel

Enterobacteriaceae, Infection
Not Provided
Travelers
Travelers and their family members
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2000
June 2016
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years
  • travelling for > 1 week (7 days) AND < 3 months (90 days)
  • non traveling household members of these traveling volunteers
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01676974
COMBAT
No
Menno D. de Jong, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Maastricht University Medical Center
  • Erasmus Medical Center
  • Utrecht University
  • ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Menno D. de Jong, PhD, MD Academisch Medisch Centrum, Amsterdam
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP