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

Study Overview
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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.

Official Title
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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

Conditions
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Drug Resistance, Multiple, Travel Medicine

Intervention / Treatment
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* Other: Improved hand hygiene


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline Group<br>Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice | |
| Active Comparator: Intervention Group<br>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) | Other: Improved hand hygiene<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia | Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers | up to 1 week after travel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting) | Incidence of travellers' diarrhoe | up to 2 weeks after travel |