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

NCT01531023 | Completed

• 1 other identifier: 2011/2214-3
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 7

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.

Conditions

Urinary Tract Infections

Keywords

Extended-Spectrum Beta-lactamase Producing Bacteria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- All patients were urinary sample taken in a primary care setting shows significant growth of ESBL producing E. coli.
• Above age 16.

You may not qualify if:

• \- Sample from patients in hospital care or living in nursing home facilities. Inability to understand and sign information leaflet.

Sponsors & Collaborators

• University of Oslo: lead
• University Hospital of North Norway: collaborator
• St. Olavs Hospital: collaborator
• Helse Stavanger HF: collaborator
• The Hospital of Vestfold: collaborator
• Vestre Viken Hospital Trust: collaborator
• University Hospital, Akershus: collaborator
• Unilabs: collaborator

Study Sites (7)

Vestre Viken Hospital Trust

Bærum, Norway

Location

University Hospital Akershus

Lørenskog, Norway

Location

Unilabs

Skien, Norway

Location

Helse Stavanger HF

Stavanger, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Vestfold Hospital Trust

Tønsberg, Norway

Location

Related Publications (1)

• 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.

  PMID: 29982514 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urinesamples

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Morten Lindbaek, Md PhD

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 10, 2012
• Study Start: April 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

NO (7)