Carriage Of Multiresistant Bacteria After Travel (COMBAT)

This study is currently recruiting participants.
Verified October 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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: October 23, 2012
Last verified: October 2012
  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 Description:

Fecal Swab


Estimated Enrollment: 2000
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: October 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676974

Contacts
Contact: John Penders, PhD +31 43 3875095 j.penders@maastrichtuniversity.nl
Contact: Jarne M. van Hattem, MD +31 20 5665026 j.m.vanhattem@amc.nl

Locations
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1100 DD
Contact: Jarne M. van Hattem, MD     +31 20 5665026     j.m.vanhattem@amc.nl    
Maastricht Universitair Medisch Centrum Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: John Penders, PhD     +31 43 3875095     j.penders@maastrichtuniversity.nl    
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Maris Arcilla, MD     +31 10 7034295     m.arcilla@erasmusmc.nl    
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

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: October 23, 2012
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 May 22, 2013