Drug Resistance, MultipleNCT03306407
The Effect of Hand Hygiene on Colonization Rates With Multidrug Resistant Enteric Pathogens in Travellers
A study testing Improved hand hygiene in people with Drug Resistance, Multiple and Travel Medicine, run by Christoph Hatz at 2 sites in Switzerland.
Trial summary
Travelling to tropical and subtropical countries is a known risk factor for becoming colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. Especially travellers returning from the Indian subcontinent show high colonization rates of up to almost 90%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Resistance, Multiple, Travel Medicine
- What is being tested?
- Improved hand hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2015to Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- age > 18 years
- travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks
Who cannot join
- age < 18 years
- travelling to other destinations than India, Bhutan and/or Nepal
- antibiotic treatment at the time of the first sampling
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Swiss Tropical and Public Health Institute
Basel, 4051
Epidemiology, Biostatistics and Prevention Institute
Zurich, 8001
About this study
Official title: A Multicentre Intervention Study on the Use of Hand Sanitizers in the Prevention of Intestinal Colonization With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Travellers to the Indian Subcontinent
Travelling to tropical and subtropical countries is a known risk factor for becoming colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. Especially travellers returning from the Indian subcontinent show high colonization rates of up to almost 90%.
While risk factors for becoming colonized have been identified in several studies, no preventive measure has been tested so far.
Read more
One of the factors associated with becoming colonized while travelling is suffering from travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school and/or work absenteeism because of diarrhoeal diseases have shown protective effects through good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in travellers through increased hand washing and the use of hand gel sanitizers might therefore not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing Enterobacteriaceae as well. However, there is no prospective data available to prove the usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in the prevention of colonization.
In the current study, investigators plan to compare colonization rates with ESBL-producing Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene (including the use of hand gel sanitizers) with travelers receiving standard advice.
- Conditions
- Drug Resistance, Multiple, Travel Medicine
- Being tested
- Improved hand hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved hand hygieneOther
The intervention group receives pre-travel advice with a special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)
| Study group | Role | What they receive |
|---|---|---|
| Baseline Group | No intervention | Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice |
| Intervention Group | Active comparator | Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received pre-travel advice with special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention) Receives: Other: Improved hand hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia
Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers
Measured: up to 1 week after travel
Secondary outcomes (1)
Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)
Incidence of travellers' diarrhoe
Measured: up to 2 weeks after travel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startDec 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug Resistance, MultipleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Hatz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Christoph Hatz, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306407
- Sponsor's protocol ID
- LEK EKNZ 2015-271
- Status last verified
- Oct 2018
- First submitted
- 9 Dec 2015
- Last updated
- 3 Oct 2018
- Results posted
- No
Publications
Kuenzli E, Jaeger VK, Frei R, Neumayr A, DeCrom S, Haller S, Blum J, Widmer AF, Furrer H, Battegay M, Endimiani A, Hatz C. High colonization rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli in Swiss travellers to South Asia- a prospective observational multicentre cohort study looking at epidemiology, microbiology and risk factors. BMC Infect Dis. 2014 Oct 1;14:528. doi: 10.1186/1471-2334-14-528.
PubMed 25270732Kantele A, Laaveri T, Mero S, Vilkman K, Pakkanen SH, Ollgren J, Antikainen J, Kirveskari J. Antimicrobials increase travelers' risk of colonization by extended-spectrum betalactamase-producing Enterobacteriaceae. Clin Infect Dis. 2015 Mar 15;60(6):837-46. doi: 10.1093/cid/ciu957. Epub 2015 Jan 21.
PubMed 25613287Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum beta-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257.
PubMed 23885972Henriey D, Delmont J, Gautret P. Does the use of alcohol-based hand gel sanitizer reduce travellers' diarrhea and gastrointestinal upset?: A preliminary survey. Travel Med Infect Dis. 2014 Sep-Oct;12(5):494-8. doi: 10.1016/j.tmaid.2014.07.002. Epub 2014 Jul 11.
PubMed 25065273
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Intervention Study on the Use of Hand Sanitizers in the Prevention of Intestinal Colonization With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Travellers to the Indian Subcontinent
- ClinicalTrials.gov ID
- NCT03306407
- Acronym / sponsor ID
- LEK EKNZ 2015-271
- Conditions
- Drug Resistance, Multiple, Travel Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Christoph HatzUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Dec 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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.
Travelling to tropical and subtropical countries is a known risk factor for becoming colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae. Especially travellers returning from the Indian subcontinent show high colonization rates of up to almost 90%.
While risk factors for becoming colonized have been identified in several studies, no preventive measure has been tested so far.
One of the factors associated with becoming colonized while travelling is suffering from travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school and/or work absenteeism because of diarrhoeal diseases have shown protective effects through good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in travellers through increased hand washing and the use of hand gel sanitizers might therefore not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing Enterobacteriaceae as well. However, there is no prospective data available to prove the usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in the prevention of colonization.
In the current study, investigators plan to compare colonization rates with ESBL-producing Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene (including the use of hand gel sanitizers) with travelers receiving standard advice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Group | No intervention | –Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice |
| Intervention Group | Active comparator | Other: Improved hand hygieneGroup screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received pre-travel advice with special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks
Key exclusion criteria (3 listed)
- age < 18 years
- travelling to other destinations than India, Bhutan and/or Nepal
- antibiotic treatment at the time of the first sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved hand hygieneThe intervention group receives pre-travel advice with a special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention) | Other | Intervention Group |
Primary outcome
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia
Time frame: up to 1 week after travel
Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers
1 secondary outcome
Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)
Time frame: up to 2 weeks after travel
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 3 Oct 2018.
- Background: PubMed 25270732Kuenzli E, Jaeger VK, Frei R, Neumayr A, DeCrom S, Haller S, Blum J, Widmer AF, Furrer H, Battegay M, Endimiani A, Hatz C. High colonization rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli in Swiss travellers to South Asia- a prospective observational multicentre cohort study looking at epidemiology, microbiology and risk factors. BMC Infect Dis. 2014 Oct 1;14:528. doi: 10.1186/1471-2334-14-528.
- Background: PubMed 25613287Kantele A, Laaveri T, Mero S, Vilkman K, Pakkanen SH, Ollgren J, Antikainen J, Kirveskari J. Antimicrobials increase travelers' risk of colonization by extended-spectrum betalactamase-producing Enterobacteriaceae. Clin Infect Dis. 2015 Mar 15;60(6):837-46. doi: 10.1093/cid/ciu957. Epub 2015 Jan 21.
- Background: PubMed 23885972Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum beta-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257.
- Background: PubMed 25065273Henriey D, Delmont J, Gautret P. Does the use of alcohol-based hand gel sanitizer reduce travellers' diarrhea and gastrointestinal upset?: A preliminary survey. Travel Med Infect Dis. 2014 Sep-Oct;12(5):494-8. doi: 10.1016/j.tmaid.2014.07.002. Epub 2014 Jul 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved hand hygiene in people with Drug Resistance, Multiple and Travel Medicine, run by Christoph Hatz at 2 sites in Switzerland.
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 2 inclusion and 3 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia (time frame: up to 1 week after travel). 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 NCT03306407, which also lists 4 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 3 Oct 2018.