Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals) (ABRESIST)

October 10, 2018 updated by: Kaidi Telling, University of Tartu

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

708

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
March 2012 - March 2014
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
March 2012 - March 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Tanel Tenson, PhD, University of Tartu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2012

Primary Completion (Actual)

January 30, 2014

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SLOTI12038T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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