The Effect of Hand Hygiene on Colonization Rates With Multidrug Resistant Enteric Pathogens in Travellers

NCT ID: NCT03306407

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Resistance, Multiple Travel Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Baseline Group

Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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)

Group Type ACTIVE_COMPARATOR

Improved hand hygiene

Intervention Type OTHER

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)

Interventions

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Improved hand hygiene

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years
* travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks

Exclusion Criteria

* age \< 18 years
* travelling to other destinations than India, Bhutan and/or Nepal
* antibiotic treatment at the time of the first sampling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Christoph Hatz

OTHER

Sponsor Role lead

Responsible Party

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Christoph Hatz

Prof. Dr. med. Christoph Hatz

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Swiss Tropical and Public Health Institute

Basel, , Switzerland

Site Status

Epidemiology, Biostatistics and Prevention Institute

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 25270732 (View on PubMed)

Kantele 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.

Reference Type BACKGROUND
PMID: 25613287 (View on PubMed)

Paltansing 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.

Reference Type BACKGROUND
PMID: 23885972 (View on PubMed)

Henriey 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.

Reference Type BACKGROUND
PMID: 25065273 (View on PubMed)

Other Identifiers

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LEK EKNZ 2015-271

Identifier Type: -

Identifier Source: org_study_id

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