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NCT03866291 Clinical Trial

ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Antibiotic Resistant Infection Clinical Trial

Official title:
ESBL-producing Enterobacteriaceae in Patients With Traveller's Diarrhoea- a Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03866291
Other study ID # 2017-0123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date June 20, 2019

Study information
Verified date July 2019
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 305
Est. completion date June 20, 2019
Est. primary completion date June 20, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Travellers diarrhoea

- foreign traveller

Exclusion Criteria:

- foreign traveller but no symptoms

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention, observational
See above

Locations
Country Name City State
Sweden Oskar Ljungquist Helsingborg Skåne

Sponsors (1)
Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion ESBL-colonized after one year. Defined as a Positive ESBL-culture obtained 12 months after travel 1 year
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