ESBL Producing E.ColiABRESISTNCT03343119
Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals)
An observational study of ESBL Producing E.Coli and ESBL Producing K.Pneumoniae, run by University of Tartu.
Trial summary
This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ESBL Producing E.Coli, ESBL Producing K.Pneumoniae, Multidrug Resistant P.Aeruginosa
- How many people
- 708 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2012to Aug 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: I group All individuals who have been hospitalised and have been diagnosed carriage or infection with multiresistant bacteria listed above. II group Children >6 months of age and all adults who have not been hospitalised or received antibacterial treatment in previous 3 months.
I group Hospitalised patients Inclusion Criteria
- MDR bacteria (listed above) isolated from clinical specimen
- hospitalisation to the Tartu University Hospital or North Estonia Medical Centre or West Tallinn Central Hospital or East-Tallinn Central Hospital or The Hospital of Reconstructive Surgery
II group Healthy volunteers Inclusion Criteria
- age >6 months
- have not received any antibacterial treatment in previous 3 months
- have not been hospitalised in previous 3 months
III group Dog owners Inclusion Criteria
- age >6 months
- have not received any antibacterial treatment in previous 3 months
- have not been hospitalised in previous 3 months
- owning a dog
IV group veterinarians Inclusion Criteria
- have not received any antibacterial treatment in previous 3 months
- have not been hospitaliZed in previous 3 months
- working as a veterinarian
V group pig farmers Inclusion Criteria
- have not received any antibacterial treatment in previous 3 months
- have not been hospitalized in previous 3 months
- occupation as a pig farmer
About this study
Official title: Transfer Routes of Antibiotic Resistance
This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalised patients | No intervention | |
| Healthy volunteers | No intervention | |
| Dog owners (healthy volunteers) | No intervention | |
| Veterinarians (healthy volunteers) | No intervention | |
| Pig farmers (healthy volunteers) | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization rate with multiresistant (MDR) bacteria in hospitalized patients
To evaluate the impact of hospitalization for carriage and infection rate with MDR bacteria
Measured: March 2012 - March 2014
Colonization rate with multiresistant (MDR) bacteria in healthy humans
To evaluate the impact of animal exposure for carriage rate with MDR bacteria
Measured: March 2012 - March 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 Mar 2012
- Primary completion30 Jan 2014
- Study completionAug 2019 (estimated)
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 ESBL Producing E.ColiStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian University of Life Sciences
- Responsible party
- Principal investigator, Kaidi Telling, University of Tartu
- Investigators
- Tanel Tenson, PhD, Study director, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343119
- Sponsor's protocol ID
- SLOTI12038T
- Acronym
- ABRESIST
- Status last verified
- Oct 2018
- First submitted
- 8 Nov 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Telling K, Laht M, Brauer A, Remm M, Kisand V, Maimets M, Tenson T, Lutsar I. Multidrug resistant Pseudomonas aeruginosa in Estonian hospitals. BMC Infect Dis. 2018 Oct 11;18(1):513. doi: 10.1186/s12879-018-3421-1.
PubMed 30309321
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer Routes of Antibiotic Resistance
- ClinicalTrials.gov ID
- NCT03343119
- Acronym / sponsor ID
- ABRESIST / SLOTI12038T
- Conditions
- ESBL Producing E.Coli, ESBL Producing K.Pneumoniae, Multidrug Resistant P.Aeruginosa, Carbapenem Resistant P.Aeruginosa, Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 708 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Estonian University of Life Sciences
- Study start
- 27 Mar 2012 (actual)
- Primary completion
- 30 Jan 2014 (actual)
- Study completion
- Aug 2019 (estimated)
- First posted
- 17 Nov 2017 (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.
This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hospitalised patients | – | –No intervention |
| Healthy volunteers | – | –No intervention |
| Dog owners (healthy volunteers) | – | –No intervention |
| Veterinarians (healthy volunteers) | – | –No intervention |
| Pig farmers (healthy volunteers) | – | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- I group All individuals who have been hospitalised and have been diagnosed carriage or infection with multiresistant bacteria listed above. II group Children >6 months of age and all adults who have not been hospitalised or received antibacterial treatment in previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colonization rate with multiresistant (MDR) bacteria in hospitalized patients
Time frame: March 2012 - March 2014
To evaluate the impact of hospitalization for carriage and infection rate with MDR bacteria
Colonization rate with multiresistant (MDR) bacteria in healthy humans
Time frame: March 2012 - March 2014
To evaluate the impact of animal exposure for carriage rate with MDR bacteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 30309321Telling K, Laht M, Brauer A, Remm M, Kisand V, Maimets M, Tenson T, Lutsar I. Multidrug resistant Pseudomonas aeruginosa in Estonian hospitals. BMC Infect Dis. 2018 Oct 11;18(1):513. doi: 10.1186/s12879-018-3421-1.
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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.
Tanel Tenson, PhD study director
University of Tartu
Questions about this trial
What is this clinical trial studying?
An observational study of ESBL Producing E.Coli and ESBL Producing K.Pneumoniae, run by University of Tartu.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Colonization rate with multiresistant (MDR) bacteria in hospitalized patients (time frame: March 2012 - March 2014). The study lists 2 primary outcomes in all. 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 NCT03343119, 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 11 Oct 2018.