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

This study has been completed.
Sponsor:
Collaborators:
University Hospital of North Norway
St. Olavs Hospital
Helse Stavanger HF
The Hospital of Vestfold
Vestre Viken Hospital Trust
University Hospital, Akershus
Unilabs
Information provided by (Responsible Party):
Marianne Bollestad, University of Oslo
ClinicalTrials.gov Identifier:
NCT01531023
First received: February 7, 2012
Last updated: October 28, 2016
Last verified: October 2016
  Purpose

The prevalence of extended spectrum beta-lactamase (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:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Number of days until symptomatic resolution [ Time Frame: Two weeks after finishing the primary antibiotic treatment ] [ Designated as safety issue: No ]
    Number of days from the start of treatment that the patient feels completely free of urinary tract symptoms Number of days after start of antibiotic treatment with mecillinam when the patient feels free of symptoms from the urinary tract


Secondary Outcome Measures:
  • Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment [ Time Frame: Two weeks after end of initial treatment ] [ Designated as safety issue: No ]
  • Number of patients who received a second treatment regime in the follow-up period [ Time Frame: 2 weeks after end of initial treatment ] [ Designated as safety issue: No ]
    Number of patients who received a secondary antibiotic treatment to obtain clinical cure.


Biospecimen Retention:   Samples With DNA
Urinesamples

Enrollment: 168
Study Start Date: April 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ESBL producing E. coli bacteria
Group of patients with identified ESBL producing E.coli in a urine sample taken in a primary care setting.
Non-ESBL E.coli urinary tract infection
E.coli bacteria found in the setting of a urinary tract infection in a primary care setting where ESBL producing bacteria are not found.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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) 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
Vestre Viken Hospital Trust
Bærum, Norway
University Hospital Akershus
Lørenskog, Norway
Unilabs
Skien, Norway
Helse Stavanger HF
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Vestfold Hospital Trust
Tønsberg, Norway
Sponsors and Collaborators
University of Oslo
University Hospital of North Norway
St. Olavs Hospital
Helse Stavanger HF
The Hospital of Vestfold
Vestre Viken Hospital Trust
University Hospital, Akershus
Unilabs
Investigators
Study Director: Morten Lindbaek, Md PhD University of Oslo
  More Information

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: October 28, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016