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

October 1, 2018 updated by: Christoph Hatz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4051
        • Swiss Tropical and Public Health Institute
      • Zurich, Switzerland, 8001
        • Epidemiology, Biostatistics and Prevention Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Baseline Group
Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice
Active Comparator: 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: up to 2 weeks after travel
Incidence of travellers' diarrhoe
up to 2 weeks after travel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christoph Hatz

Collaborators

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LEK EKNZ 2015-271

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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