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

NCT03306407 | Completed

• 1 other identifier: LEK EKNZ 2015-271
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

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.

Conditions

Drug Resistance, Multiple; Travel Medicine

Outcome Measures

Primary Outcomes (1)

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

  Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers

  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)

  up to 2 weeks after travel

Study Arms (2)

Baseline Group

NO INTERVENTION

Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice

Intervention Group

ACTIVE COMPARATOR

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

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)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks

You may not qualify if:

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

Sponsors & Collaborators

• Christoph Hatz: lead
• University of Zurich: collaborator

Study Sites (2)

Swiss Tropical and Public Health Institute

Basel, 4051, Switzerland

Location

Epidemiology, Biostatistics and Prevention Institute

Zurich, 8001, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 25270732 BACKGROUND

• 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.

  PMID: 25613287 BACKGROUND

• 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.

  PMID: 23885972 BACKGROUND

• 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.

  PMID: 25065273 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Christoph Hatz

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: October 11, 2017
• Study Start: December 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

CH (2)