Antibiotic Resistant InfectionNCT03866291
ESBL in Patients Returning to Sweden With Traveller's Diarrhoea
An observational study of Antibiotic Resistant Infection and Antibiotic Resistant Strain, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Resistant Infection, Antibiotic Resistant Strain, Traveler's Diarrhea
- How many people
- 305 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 20 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Travellers of all ages
Who may be able to join
- Travellers diarrhoea
- foreign traveller
Who cannot join
- foreign traveller but no symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESBL-producing Enterobacteriaceae in Patients With Traveller's Diarrhoea- a Prospective Cohort Study.
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.
Read the 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.
- Being tested
- No intervention, observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationalOther
See above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion ESBL-colonized after one year.
Defined as a Positive ESBL-culture obtained 12 months after travel
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Feb 2017
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oskar Ljungquist, Principal investigator, Lunds Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866291
- Sponsor's protocol ID
- 2017-0123
- Status last verified
- Jul 2019
- First submitted
- 27 Feb 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32988817
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESBL-producing Enterobacteriaceae in Patients With Traveller's Diarrhoea- a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03866291
- Acronym / sponsor ID
- 2017-0123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESBL carrier | – | Other: No intervention, observationalThis 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 | – | Other: No intervention, observationalNo 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Travellers of all ages
Key inclusion criteria (2 listed)
- Travellers diarrhoea
- foreign traveller
Key exclusion criteria (1 listed)
- foreign traveller but no symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observationalSee above | Other | ESBL carrier, Non ESBL-carrier |
Primary outcome
Proportion ESBL-colonized after one year.
Time frame: 1 year
Defined as a Positive ESBL-culture obtained 12 months after travel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Derived from this study: PubMed 32988817Ljungquist 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.
- Individual participant dataSharing planned: Undecided
Related trials for Antibiotic Resistant Infection
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskar Ljungquist principal investigator
Lunds Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Infection and Antibiotic Resistant Strain, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion ESBL-colonized after one year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.