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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
  Purpose

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.


Condition
Enterobacteriaceae, Infection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Fecal Swab


Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Travelers
Travelers and their family members

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Travelers and their family members not planning to travel

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676974

Locations
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1100 DD
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands, 6202 AZ
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
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
Investigators
Principal Investigator: Menno D. de Jong, PhD, MD Academisch Medisch Centrum, Amsterdam
  More Information

No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Menno D. de Jong, MD, Prof. dr. M.D. de Jong, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01676974     History of Changes
Other Study ID Numbers: COMBAT
Study First Received: August 29, 2012
Last Updated: January 14, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Drug Resistance, Microbial
Enterobacteriaceae
ESBL
Carbapenemase
Travel

ClinicalTrials.gov processed this record on November 23, 2014