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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestre Viken Hospital Trust, Bærum, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of days until symptomatic resolution

Time frame: Two weeks after finishing the primary antibiotic treatment

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 outcomes

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
Number of patients who received a second treatment regime in the follow-up period

Time frame: 2 weeks after end of initial treatment

Number of patients who received a secondary antibiotic treatment to obtain clinical cure.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

Helse Stavanger HF
St. Olavs Hospital
The Hospital of Vestfold
Unilabs
University Hospital of North Norway
University Hospital, Akershus
Vestre Viken Hospital Trust

Registry information

Official study title

What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Feb 10, 2012
Registry last updated: Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed