ESBL in Patients Returning to Sweden With Traveller's Diarrhoea

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT03866291

Collaborator

(none)

305

Enrollment

Location

28.6

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antibiotic Resistant Infection Antibiotic Resistant Strain Traveler's Diarrhea	Other: No intervention, observational

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 Design

Study Type:

Observational

Actual Enrollment :

305 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Jun 20, 2019

Actual Study Completion Date :

Jun 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
ESBL carrier 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.	Other: No intervention, observational See above
Non ESBL-carrier 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.	Other: No intervention, observational See above

Arm

Intervention/Treatment

ESBL carrier

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.

Other: No intervention, observational

See above

Non ESBL-carrier

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.

Other: No intervention, observational

See above

Outcome Measures

Primary Outcome Measures

Proportion ESBL-colonized after one year. [1 year]
Defined as a Positive ESBL-culture obtained 12 months after travel

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Travellers diarrhoea
foreign traveller

Exclusion Criteria:

foreign traveller but no symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oskar Ljungquist	Helsingborg	Skåne	Sweden	25187

Sponsors and Collaborators

Lund University

Investigators

Principal Investigator: Oskar Ljungquist, Lunds Universitet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lund University

ClinicalTrials.gov Identifier:

NCT03866291

Other Study ID Numbers:

2017-0123

First Posted:

Mar 7, 2019

Last Update Posted:

Jul 2, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dysentery

Diarrhea

Study Results

No Results Posted as of Jul 2, 2019