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Clinical Trials/NCT01531023
NCT01531023CompletedNot Applicable

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

University of Oslo7 sites in 1 country168 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
168
Locations
7
Primary Endpoint
Number of days until symptomatic resolution

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marianne Bollestad

MD

University of Oslo

Study Sites (7)

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