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.
Urinary Tract Infections
|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?|
- 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
- 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
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531023
|Contact: Marianne Bollestad, Mdfirstname.lastname@example.org|
|Vestre Viken Hospital Trust||Recruiting|
|Contact: Pål Arne Jenum, PhD email@example.com|
|Sub-Investigator: Synne Jenum, MD|
|University Hospital Akershus||Recruiting|
|Contact: Heidi Johanne Espvik, MD firstname.lastname@example.org|
|Contact: Andreas Emmert, MD email@example.com|
|Helse Stavanger HF||Recruiting|
|Contact: Monica R Romstad, MD firstname.lastname@example.org|
|University Hospital of North Norway||Recruiting|
|Contact: Sigrid Solhaug, MD sigrid@email@example.com|
|St Olavs Hospital||Recruiting|
|Contact: Hans-Johnny S Nilsen, MD firstname.lastname@example.org|
|Vestfold Hospital Trust||Recruiting|
|Contact: Nils Grude, PhD email@example.com|
|Sub-Investigator: Yngvar Tveten, PhD|
|Study Director:||Morten Lindbaek, Md PhD||University of Oslo|