Treatment of Extended Spectrum Betalactamase Producing Bacteria Causing Urinary Tract Infections in General Practice
|ClinicalTrials.gov Identifier: NCT01531023|
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : October 31, 2016
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 or disease|
|Urinary Tract Infections|
|Study Type :||Observational|
|Actual Enrollment :||168 participants|
|Observational Model:||Case Control|
|Official Title:||What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
- 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
- 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531023
|Vestre Viken Hospital Trust|
|University Hospital Akershus|
|Helse Stavanger HF|
|University Hospital of North Norway|
|St Olavs Hospital|
|Vestfold Hospital Trust|
|Study Director:||Morten Lindbaek, Md PhD||University of Oslo|