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

Completed

• Conditions: Urinary Tract Infections

• Registration Number: NCT01531023
• Lead Sponsor: University of Oslo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2013-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of days until symptomatic resolution	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 Outcome Measures

Name	Time	Method
Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment	Two weeks after end of initial treatment
Number of patients who received a second treatment regime in the follow-up period	2 weeks after end of initial treatment	Number of patients who received a secondary antibiotic treatment to obtain clinical cure.

Trial Locations

Locations (7)

Vestre Viken Hospital Trust; 🇳🇴 Bærum, Norway

Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

University Hospital Akershus; 🇳🇴 Lørenskog, Norway

Unilabs; 🇳🇴 Skien, Norway

Helse Stavanger HF; 🇳🇴 Stavanger, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway