Clinical trial NCT01531023: Treatment of Extended Spectrum Betalactamase Producing Bacteria Causing Urinary Tract Infections in General Practice
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: Extended-Spectrum Beta-lactamase Producing Bacteria
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: St. Olavs Hospital
name: Helse Stavanger HF
name: The Hospital of Vestfold
name: Vestre Viken Hospital Trust
name: University Hospital, Akershus
name: Unilabs
First posted: 2012-02-10
Enrollment: 168
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of days until symptomatic resolution
timeFrame: Two weeks after finishing the primary antibiotic treatment
Secondary outcomes:
measure: Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment
timeFrame: Two weeks after end of initial treatment
measure: Number of patients who received a second treatment regime in the follow-up period
timeFrame: 2 weeks after end of initial treatment
Other outcomes:
Locations:
city: Bærum
country: Norway
facility: Vestre Viken Hospital Trust
city: Lørenskog
country: Norway
facility: University Hospital Akershus
city: Skien
country: Norway
facility: Unilabs
city: Stavanger
country: Norway
facility: Helse Stavanger HF
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
affiliation: University of Oslo
name: Morten Lindbaek, Md PhD
role: STUDY_DIRECTOR
References:
citation: Bollestad M, Grude N, Solhaug S, Raffelsberger N, Handal N, Nilsen HS, Romstad MR, Emmert A, Tveten Y, Soraas A, Jenum PA, Jenum S, Moller-Stray J, Weme ET, Lindbaek M, Simonsen GS; (the Norwegian ESBL UTI study group). Clinical and bacteriological efficacy of pivmecillinam treatment for uncomplicated urinary tract infections caused by ESBL-producing Escherichia coli: a prospective, multicentre, observational cohort study. J Antimicrob Chemother. 2018 Sep 1;73(9):2503-2509. doi: 10.1093/jac/dky230.