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Clinical Trials/NCT03306407
NCT03306407
Completed
Not Applicable

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

Christoph Hatz2 sites in 1 country290 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drug Resistance, Multiple
Sponsor
Christoph Hatz
Enrollment
290
Locations
2
Primary Endpoint
Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Christoph Hatz
Responsible Party
Sponsor Investigator
Principal Investigator

Christoph Hatz

Prof. Dr. med. Christoph Hatz

Swiss Tropical & Public Health Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (2)

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