NCT03866291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

February 27, 2019

Last Update Submit

July 1, 2019

Conditions

Antibiotic Resistant InfectionAntibiotic Resistant StrainTraveler's Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Proportion ESBL-colonized after one year.

    Defined as a Positive ESBL-culture obtained 12 months after travel

    1 year

Study Arms (2)

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

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

Interventions

No intervention, observationalOTHER

See above

ESBL carrierNon ESBL-carrier

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Travellers of all ages

You may qualify if:

  • Travellers diarrhoea
  • foreign traveller

You may not qualify if:

  • foreign traveller but no symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oskar Ljungquist

Helsingborg, Skåne County, 25187, Sweden

Location

Related Publications (1)

  • Ljungquist O, Camporeale A, Nematzadeh S, Giske CG, Resman F, Riesbeck K, Tham J. A Cross-Sectional Cohort Study of Extended-Spectrum-Beta-Lactamase-Producing Enterobacterales in Patients with Traveler's Diarrhea. Antimicrob Agents Chemother. 2020 Nov 17;64(12):e01585-20. doi: 10.1128/AAC.01585-20. Print 2020 Nov 17.

    PMID: 32988817DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Rectal cultures and blood samples

Study Officials

  • Oskar Ljungquist

    Lunds Universitet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 7, 2019

Study Start

February 1, 2017

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07

Locations

SE(1)