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

Drug Resistance, Multiple Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306407
• Other study ID #: LEK EKNZ 2015-271
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: July 2018

Study information

• Verified date: October 2018
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistance, Multiple
• Travel Medicine

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)

Locations

Country	Name	City	State
Switzerland	Swiss Tropical and Public Health Institute	Basel
Switzerland	Epidemiology, Biostatistics and Prevention Institute	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Christoph Hatz	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View Citation

Kantele A, Lääveri 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. — View Citation

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 ß-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. — View Citation

Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum ß-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)	Incidence of travellers' diarrhoe	up to 2 weeks after travel