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Trial record 1 of 1 for:    NCT03343119
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Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals) (ABRESIST)

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ClinicalTrials.gov Identifier: NCT03343119
Recruitment Status : Unknown
Verified October 2018 by Kaidi Telling, University of Tartu.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Estonian University of Life Sciences
Information provided by (Responsible Party):
Kaidi Telling, University of Tartu

Study Description
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Brief 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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 708 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Transfer Routes of Antibiotic Resistance
Actual Study Start Date : March 27, 2012
Actual Primary Completion Date : January 30, 2014
Estimated Study Completion Date : August 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
DNA from isolated multiresistant bacteria

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343119


Sponsors and Collaborators
University of Tartu
Estonian University of Life Sciences
Investigators
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Study Director: Tanel Tenson, PhD University of Tartu
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaidi Telling, MD, University of Tartu
ClinicalTrials.gov Identifier: NCT03343119    
Other Study ID Numbers: SLOTI12038T
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases