Carriage Of Multiresistant Bacteria After Travel

Enterobacteriaceae, Infection Clinical Trial

— COMBAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676974
• Other study ID #: COMBAT
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: July 29, 2016
• Start date: November 2012
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2215
• Est. completion date: July 2016
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• travelling for > 1 week (7 days) AND < 3 months (90 days)

• non traveling household members of these traveling volunteers

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterobacteriaceae, Infection

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam

Sponsors (5)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Erasmus Medical Center, Maastricht University Medical Center, Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acquisition rate	the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel	1 year	No
Secondary	duration of colonization		1 year	No
Secondary	rate of secondary transmission within households		1 year	No
Secondary	identification of risk factors		1 year	No
Secondary	occurrence of self-reported infections in the year following travel		1 year	No
Secondary	abundance and type of resistance		1 year	No