NCT03343119

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
unknown

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

March 27, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

November 8, 2017

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Colonization rate with multiresistant (MDR) bacteria in hospitalized patients

    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

    To evaluate the impact of animal exposure for carriage rate with MDR bacteria

    March 2012 - March 2014

Study Arms (5)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • age \>6 months
  • have not received any antibacterial treatment in previous 3 months
  • have not been hospitalised in previous 3 months
  • age \>6 months
  • have not received any antibacterial treatment in previous 3 months
  • have not been hospitalised in previous 3 months
  • owning a dog
  • have not received any antibacterial treatment in previous 3 months
  • have not been hospitaliZed in previous 3 months
  • working as a veterinarian
  • have not received any antibacterial treatment in previous 3 months
  • have not been hospitalized in previous 3 months
  • occupation as a pig farmer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA from isolated multiresistant bacteria

Study Officials

  • Tanel Tenson, PhD

    University of Tartu

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 17, 2017

Study Start

March 27, 2012

Primary Completion

January 30, 2014

Study Completion

August 1, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10