Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients

Completed

• Conditions: Urinary Tract Infection; Environmental Contamination of ESBL; Infection Due to ESBL Bacteria

• Registration Number: NCT01838213
• Lead Sponsor: Vestre Viken Hospital Trust

Brief Summary

This project aims at investigating the duration of human fecal carriage of bacteria harboring plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk factors for infections with such bacteria and persistence, mobility and spread of ESBL in the environment and within households. It also aims to compare different methods of detecting ESBL carriage and treat patients with urinary tract infection caused by these bacteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Primary Completion: 2014-12
• Results First Submitted: 2015-07-24
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-21
• Last Update Submitted: 2015-10-21
• Results First Posted: 2015-11-23
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 760

Inclusion Criteria

• Patients >=18 of age with a urine culture yielding E. coli or K. pneumoniae >10.000 colony forming units/mL.

Exclusion Criteria

• Patients who have lived in Norway for <1 year
• Patients who are unable to answer a questionaire
• Patients who have been infected with an ESBL producing bacteria before
• Patients who have been admitted to a hospital or a long term care facility for >24 hours during the past 31 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Failure	14 days after initiation of treatment	Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne "High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli" the mecillinam treatment group were compared with the group that did not receive mecillinam.

Secondary Outcome Measures

Name	Time	Method
Subjective Outcome	14 days	A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.