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

Not Applicable

Completed

• Conditions: Drug Resistance, Multiple; Travel Medicine
• Interventions: Other: Improved hand hygiene

• Registration Number: NCT03306407
• Lead Sponsor: Christoph Hatz

Brief 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%.

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

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Improved hand hygiene	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)

Primary Outcome Measures

Name	Time	Method
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia	up to 1 week after travel	Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers

Secondary Outcome Measures

Name	Time	Method
Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)	up to 2 weeks after travel	Incidence of travellers' diarrhoe

Trial Locations

Locations (2)

Swiss Tropical and Public Health Institute; 🇨🇭 Basel, Switzerland

Epidemiology, Biostatistics and Prevention Institute; 🇨🇭 Zurich, Switzerland