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Treatment of Extended Spectrum Betalactamase Producing Bacteria Causing Urinary Tract Infections in General Practice

This study is not yet open for participant recruitment.
Verified February 2012 by University of Oslo
Sponsor:
Information provided by (Responsible Party):
Marianne Bollestad, University of Oslo
ClinicalTrials.gov Identifier:
NCT01531023
First received: February 7, 2012
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

The prevalence of extended spectrum betalactamase (ESBL) producing bacteria found in urine sample cultures has been increasing over the past decades.

The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and microbiological outcome of the same group of bacteria treated with other antiinfectious agents.

Samples are gathered in primary care setting.


Condition
Urinary Tract Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Biospecimen Retention:   Samples With DNA

Urinesamples


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ESBL producing bacteria
Group of patients with identified ESBL producing bacteria in a urine sample taken in a primary care setting.
Non-ESBL urinary tract infection
Urinary tract infection found in sample taken in a primary care setting where ESBL producing bacteria are not found.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will be selected from all patients ages 16 and over who are diagnosed with an urinary tract infection where an ESBL producing bacteria (E. coli or K. Pneumoniae) is found. The urinary tract infection must be diagnosed and treated in a primary care setting.

Criteria

Inclusion Criteria:

- All patients were urinary sample taken in a primary care setting shows significant growth of ESBL producing K. pneumoniae or E. coli.

Above age 16.

Exclusion Criteria:

- Sample from patients in hospital care or living in nursing home facilities. Inability to understand and sign information leaflet.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531023

Contacts
Contact: Marianne Bollestad, Md +4798488454 mbollestad@hotmail.com

Sponsors and Collaborators
University of Oslo
Investigators
Study Director: Morten Lindbaek, Md PhD University of Oslo
  More Information

No publications provided

Responsible Party: Marianne Bollestad, MD, University of Oslo
ClinicalTrials.gov Identifier: NCT01531023     History of Changes
Other Study ID Numbers: 2011/2214-3
Study First Received: February 7, 2012
Last Updated: February 9, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Extended-Spectrum Betalactamese Producing Bacteria

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013