Clinical trial NCT01838213: Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients
Official title: Extended Spectrum Beta-lactamases - Treatment, Carriage, Environmental Dissemination And Population Epidemiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Infection Due to ESBL Bacteria
Environmental Contamination of ESBL
Keywords: Urinary tract infection
ESBL
treatment
carriage
risk factors
water contamination
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
name: University Hospital of North Norway
name: University of Oslo
First posted: 2013-04-23
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in Eastern Norway who have an urine submitted for culturing to the Department of Medical Microbiology, Vestre Viken Hospital Trust, which covers an area of about 450.000 inhabitants.

All patients with an bacteria producing ESBL were eligible while patients without ESBL producing bacteria were randomly sampled.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Failure
timeFrame: 14 days after initiation of treatment
Secondary outcomes:
measure: Subjective Outcome
timeFrame: 14 days
Other outcomes:
measure: Carriage of ESBL Producing Bacteria
timeFrame: up to 3 years
Locations:
Study officials:
affiliation: Vestre Viken Hospital Trust
name: Pål A Jenum, PhD
role: STUDY_DIRECTOR
References:
citation: Soraas A, Sundsfjord A, Jorgensen SB, Liestol K, Jenum PA. High rate of per oral mecillinam treatment failure in community-acquired urinary tract infections caused by ESBL-producing Escherichia coli. PLoS One. 2014 Jan 15;9(1):e85889. doi: 10.1371/journal.pone.0085889. eCollection 2014.
citation: Soraas A, Sundsfjord A, Sandven I, Brunborg C, Jenum PA. Risk factors for community-acquired urinary tract infections caused by ESBL-producing enterobacteriaceae--a case-control study in a low prevalence country. PLoS One. 2013 Jul 23;8(7):e69581. doi: 10.1371/journal.pone.0069581. Print 2013.
citation: Soraas A, Olsen I, Sundsfjord A, Handal T, Bjorang O, Jenum PA. Extended-spectrum beta-lactamase-producing bacteria are not detected in supragingival plaque samples from human fecal carriers of ESBL-producing Enterobacteriaceae. J Oral Microbiol. 2014 Aug 20;6. doi: 10.3402/jom.v6.24026. eCollection 2014.