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

Christoph Hatz

Status: Completed

Conditions: Drug Resistance, Multiple; Travel Medicine

Treatments: Other: Improved hand hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT03306407

LEK EKNZ 2015-271

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Baseline Group

No Intervention group

Description:

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

Intervention Group

Active Comparator group

Description:

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)

Treatment:

Other: Improved hand hygiene