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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Oslo
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: December 2, 2014
Last verified: December 2014
  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


Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
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

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

Locations
Norway
Vestre Viken Hospital Trust Recruiting
Bærum, Norway
Contact: Pål Arne Jenum, PhD       palarne.jenum@vestreviken.no   
Sub-Investigator: Synne Jenum, MD         
University Hospital Akershus Recruiting
Lørenskog, Norway
Contact: Heidi Johanne Espvik, MD       heidi.johanne.espvik@ahus.no   
Unilabs Recruiting
Skien, Norway
Contact: Andreas Emmert, MD       andreas.emmert@unilabs.com   
Helse Stavanger HF Recruiting
Stavanger, Norway
Contact: Monica R Romstad, MD       monica.regine.romstad@sus.no   
University Hospital of North Norway Recruiting
Tromsø, Norway
Contact: Sigrid Solhaug, MD       sigrid@solhaug@unn.no   
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Hans-Johnny S Nilsen, MD       hans-johnny.schjelderup.nilsen@stolav.no   
Vestfold Hospital Trust Recruiting
Tønsberg, Norway
Contact: Nils Grude, PhD       nigrud@siv.no   
Sub-Investigator: Yngvar Tveten, PhD         
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

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: December 2, 2014
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
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on July 01, 2015