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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531023
• Other study ID #: 2011/2214-3
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: October 28, 2016
• Start date: April 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
Norway	Vestre Viken Hospital Trust	Bærum
Norway	University Hospital Akershus	Lørenskog
Norway	Unilabs	Skien
Norway	Helse Stavanger HF	Stavanger
Norway	Vestfold Hospital Trust	Tønsberg
Norway	University Hospital of North Norway	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
University of Oslo	Helse Stavanger HF, St. Olavs Hospital, The Hospital of Vestfold, Unilabs, University Hospital of North Norway, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days until symptomatic resolution	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	Two weeks after finishing the primary antibiotic treatment	No
Secondary	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	No
Secondary	Number of patients who received a second treatment regime in the follow-up period	Number of patients who received a secondary antibiotic treatment to obtain clinical cure.	2 weeks after end of initial treatment	No