ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Completed

• Conditions: Traveler's Diarrhea; Antibiotic Resistant Strain; Antibiotic Resistant Infection
• Interventions: Other: No intervention, observational

• Registration Number: NCT03866291
• Lead Sponsor: Lund University

Brief Summary

Patients with traveller's diarrhoea frequently harbour Extended Spectrum Betalactamase (ESBL)-producing Enterobacteriaceae (EPE) returning from EPE-endemic areas.

This study investigates to what extent travellers returning to Sweden with traveller's diarrhoea carry ESBL in their stool. The isolates are examined further according to species, phenotype, antibiogram and whole genome sequencing.

Detailed Description

Samples sent to the department of clinical microbiology in Lund, Sweden for culture of salmonella, shigella, yersinia or campylobacter are also cultured selectively for ESBL.

All patients are contacted by mail with the results. ESBL-positive patients are invited to submit further faecal cultures and blood samples during one year follow up time, to investigate how long the patient is colonized with ESBL.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

• Travellers diarrhoea
• foreign traveller

Exclusion Criteria

• foreign traveller but no symptoms

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESBL carrier	No intervention, observational	This cohort is followed for a year with additional selective ESBL cultures after 1, 3, 6 and 12 months. In the end of the year a questionnaire is handed in to the study group. Sera is donated after 4-6 weeks and in year.
Non ESBL-carrier	No intervention, observational	No further rectal cultures. In the end of the year a questionnaire is handed in to the study group. Sera is donated after 4-6 weeks and in year.

Primary Outcome Measures

Name	Time	Method
Proportion ESBL-colonized after one year.	1 year	Defined as a Positive ESBL-culture obtained 12 months after travel

Trial Locations

Locations (1)

Oskar Ljungquist; 🇸🇪 Helsingborg, Skåne, Sweden