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

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.

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Key information

Conditions

Urinary Tract Infection Environmental Contamination of ESBL Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infection Due to ESBL Bacteria Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Treatment Failure

Time frame: 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 outcomes

Subjective Outcome

Time frame: 14 days

A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.

Other outcomes

Carriage of ESBL Producing Bacteria

Time frame: up to 3 years

Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

Helse Sor-Ost
University Hospital of North Norway
University of Oslo

Registry information

Official study title

Extended Spectrum Beta-lactamases - Treatment, Carriage, Environmental Dissemination And Population Epidemiology

Acronym: ESCAPE

Important dates

Study start: 2009
Primary completion: 2014
First posted: Apr 23, 2013
Registry last updated: Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed