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CompletedNCT03306407Updated Oct 3, 2018

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

An interventional study of Improved hand hygiene in Drug Resistance, Multiple and Travel Medicine, sponsored by Christoph Hatz. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by Christoph Hatz · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
290
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Resistance, Multiple
  • Travel Medicine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • age \< 18 years
  • travelling to other destinations than India, Bhutan and/or Nepal
  • antibiotic treatment at the time of the first sampling
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
290 participants (actual)

Study arms

  • 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

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)

05

What researchers measure

Primary outcomes

  1. Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia

    Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers

    Time frame: up to 1 week after travel

Secondary outcomes

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

    Incidence of travellers' diarrhoe

    Time frame: up to 2 weeks after travel

06

Study locations

2 sites
  • Swiss Tropical and Public Health Institute
    Basel, 4051, Switzerland
  • Epidemiology, Biostatistics and Prevention Institute
    Zurich, 8001, Switzerland
07

References and documents

Publications

  • Kuenzli E, Jaeger VK, Frei R, Neumayr A, DeCrom S, Haller S, Blum J, Widmer AF, Furrer H, Battegay M, Endimiani A, Hatz C. High colonization rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli in Swiss travellers to South Asia- a prospective observational multicentre cohort study looking at epidemiology, microbiology and risk factors. BMC Infect Dis. 2014 Oct 1;14:528. doi: 10.1186/1471-2334-14-528. PubMed 25270732 ↗
  • Kantele A, Laaveri T, Mero S, Vilkman K, Pakkanen SH, Ollgren J, Antikainen J, Kirveskari J. Antimicrobials increase travelers' risk of colonization by extended-spectrum betalactamase-producing Enterobacteriaceae. Clin Infect Dis. 2015 Mar 15;60(6):837-46. doi: 10.1093/cid/ciu957. Epub 2015 Jan 21. PubMed 25613287 ↗
  • Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum beta-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257. PubMed 23885972 ↗
  • Henriey D, Delmont J, Gautret P. Does the use of alcohol-based hand gel sanitizer reduce travellers' diarrhea and gastrointestinal upset?: A preliminary survey. Travel Med Infect Dis. 2014 Sep-Oct;12(5):494-8. doi: 10.1016/j.tmaid.2014.07.002. Epub 2014 Jul 11. PubMed 25065273 ↗
08

Registry details

Key details

Study ID
NCT03306407
Lead sponsor
Christoph Hatz
Collaborators
University of Zurich
Responsible party
Christoph Hatz (Prof. Dr. med. Christoph Hatz, Swiss Tropical & Public Health Institute) — Sponsor-investigator
First posted
Oct 11, 2017
Start date
Dec 2015
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Oct 3, 2018
View the source record on ClinicalTrials.gov ↗

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