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

Urinary Tract Infection Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838213
• Other study ID #: REK S-08901b
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: October 21, 2015
• Start date: February 2009

Study information

• Verified date: October 2015
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Environmental Contamination of ESBL
• Infection
• Infection Due to ESBL Bacteria
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Helse Sor-Ost, University Hospital of North Norway, University of Oslo

References & Publications (3)

Søraas A, Olsen I, Sundsfjord A, Handal T, Bjørang 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 — View Citation

Søraas A, Sundsfjord A, Jørgensen SB, Liestøl 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 — View Citation

Søraas 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carriage of ESBL Producing Bacteria	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.	up to 3 years	No
Primary	Treatment Failure	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.	14 days after initiation of treatment	No
Secondary	Subjective Outcome	A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.	14 days	No