Carriage Of Multiresistant Bacteria After Travel (COMBAT)
|ClinicalTrials.gov Identifier: NCT01676974|
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : August 1, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||2215 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||July 2016|
Travelers and their family members
- acquisition rate [ Time Frame: 1 year ]the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel
- duration of colonization [ Time Frame: 1 year ]
- rate of secondary transmission within households [ Time Frame: 1 year ]
- identification of risk factors [ Time Frame: 1 year ]
- occurrence of self-reported infections in the year following travel [ Time Frame: 1 year ]
- abundance and type of resistance [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676974
|Academisch Medisch Centrum|
|Amsterdam, Netherlands, 1100 DD|
|Maastricht Universitair Medisch Centrum|
|Maastricht, Netherlands, 6202 AZ|
|Erasmus Medisch Centrum|
|Rotterdam, Netherlands, 3000 CA|
|Principal Investigator:||Menno D. de Jong, PhD, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|