Enterobacteriaceae, InfectionCOMBATNCT01676974
Carriage Of Multiresistant Bacteria After Travel
An observational study of Enterobacteriaceae, Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enterobacteriaceae, Infection
- How many people
- 2,215 participants
- Where
- 3 sitesNetherlands
- Study dates
- Nov 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Travelers and their family members not planning to travel
Who may be able to join
- age > 18 years
- travelling for > 1 week (7 days) AND < 3 months (90 days)
- non traveling household members of these traveling volunteers
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam, 1100 DD
Maastricht Universitair Medisch Centrum
Maastricht, 6202 AZ
Erasmus Medisch Centrum
Rotterdam, 3000 CA
About this study
Official title: 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.
Read the 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.
- Conditions
- Enterobacteriaceae, Infection
- Keywords
- Drug Resistance, Microbial, Enterobacteriaceae, ESBL, Carbapenemase, Travel
- Medical subject headings
- Enterobacteriaceae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Travelers | Travelers and their family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
acquisition rate
the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel
Measured: 1 year
Secondary outcomes (5)
duration of colonization
Measured: 1 year
rate of secondary transmission within households
Measured: 1 year
identification of risk factors
Measured: 1 year
occurrence of self-reported infections in the year following travel
Measured: 1 year
abundance and type of resistance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enterobacteriaceae, InfectionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 2,215 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Erasmus Medical Center, Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Menno D. de Jong, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Menno D. de Jong, PhD, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676974
- Sponsor's protocol ID
- COMBAT
- Acronym
- COMBAT
- Status last verified
- Jul 2016
- First submitted
- 29 Aug 2012
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Arcilla MS, van Hattem JM, Haverkate MR, Bootsma MCJ, van Genderen PJJ, Goorhuis A, Grobusch MP, Lashof AMO, Molhoek N, Schultsz C, Stobberingh EE, Verbrugh HA, de Jong MD, Melles DC, Penders J. Import and spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae by international travellers (COMBAT study): a prospective, multicentre cohort study. Lancet Infect Dis. 2017 Jan;17(1):78-85. doi: 10.1016/S1473-3099(16)30319-X. Epub 2016 Oct 14.
PubMed 27751772Arcilla 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.
PubMed 24775515
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands
- ClinicalTrials.gov ID
- NCT01676974
- Acronym / sponsor ID
- COMBAT / COMBAT
- Conditions
- Enterobacteriaceae, Infection
- Keywords
- Drug Resistance, Microbial, Enterobacteriaceae, ESBL, Carbapenemase, Travel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,215 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Maastricht University Medical Center, Erasmus Medical Center, Utrecht University, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Travelers | – | –Travelers and their family members |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Travelers and their family members not planning to travel
Key inclusion criteria (3 listed)
- age > 18 years
- travelling for > 1 week (7 days) AND < 3 months (90 days)
- non traveling household members of these traveling volunteers
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acquisition rate
Time frame: 1 year
the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Derived from this study: PubMed 27751772Arcilla MS, van Hattem JM, Haverkate MR, Bootsma MCJ, van Genderen PJJ, Goorhuis A, Grobusch MP, Lashof AMO, Molhoek N, Schultsz C, Stobberingh EE, Verbrugh HA, de Jong MD, Melles DC, Penders J. Import and spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae by international travellers (COMBAT study): a prospective, multicentre cohort study. Lancet Infect Dis. 2017 Jan;17(1):78-85. doi: 10.1016/S1473-3099(16)30319-X. Epub 2016 Oct 14.
- Derived from this study: PubMed 24775515Arcilla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menno D. de Jong, PhD, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterobacteriaceae, Infection, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acquisition rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01676974, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.