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OpenTrials
Completed

NCT Number: NCT03306407

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Tropical and Public Health Institute, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Improved hand hygiene

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)

    Time frame: up to 2 weeks after travel

    Incidence of travellers' diarrhoe

Sponsors and collaborators

Lead sponsor

Christoph Hatz

Other

Collaborators

  • University of Zurich

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2017
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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