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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03306407
Enrollment
290
Registered
2017-10-11
Start date
2015-12-31
Completion date
2018-07-31
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Resistance, Multiple, Travel Medicine

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.

Interventions

OTHERImproved 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)

Sponsors

University of Zurich
CollaboratorOTHER
Christoph Hatz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asiaup to 1 week after travelColoinzation rates with ESBL-producing Enterobacteriaceae in travellers

Secondary

MeasureTime frameDescription
Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)up to 2 weeks after travelIncidence of travellers' diarrhoe

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026