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

Sponsor
Christoph Hatz (Other)
Overall Status
Completed
CT.gov ID
NCT03306407
Collaborator
University of Zurich (Other)
290
2
2
31
145
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Improved hand hygiene
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
290 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official 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
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Swiss Tropical and Public Health Institute Basel Switzerland 4051
2 Epidemiology, Biostatistics and Prevention Institute Zurich Switzerland 8001

Sponsors and Collaborators

  • Christoph Hatz
  • University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Christoph Hatz, Prof. Dr. med. Christoph Hatz, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT03306407
Other Study ID Numbers:
  • LEK EKNZ 2015-271
First Posted:
Oct 11, 2017
Last Update Posted:
Oct 3, 2018
Last Verified:
Oct 1, 2018

Study Results

No Results Posted as of Oct 3, 2018