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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01531023
Enrollment
168
Registered
2012-02-10
Start date
2013-04-30
Completion date
2016-09-30
Last updated
2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Extended-Spectrum Beta-lactamase Producing Bacteria

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.

Interventions

None listed

Sponsors

University Hospital of North Norway
CollaboratorOTHER
St. Olavs Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
The Hospital of Vestfold
CollaboratorOTHER
Vestre Viken Hospital Trust
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Unilabs
CollaboratorUNKNOWN
University of Oslo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of days until symptomatic resolutionTwo weeks after finishing the primary antibiotic treatmentNumber 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

MeasureTime frameDescription
Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatmentTwo weeks after end of initial treatment
Number of patients who received a second treatment regime in the follow-up period2 weeks after end of initial treatmentNumber of patients who received a secondary antibiotic treatment to obtain clinical cure.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026