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

NCT01838213 | Completed Results

• 1 other identifier: REK S-08901b
• Study Type: observational
• Target: 760
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infection; Infection Due to ESBL Bacteria; Environmental Contamination of ESBL

Keywords

Urinary tract infection; ESBL; treatment; carriage; risk factors; water contamination

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Subjective Outcome

  14 days

Other Outcomes (1)

• Carriage of ESBL Producing Bacteria

  up to 3 years

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Helse Sor-Ost: collaborator
• University Hospital of North Norway: collaborator
• University of Oslo: collaborator

Related Publications (3)

• 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.

  PMID: 24454943 RESULT

• 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.

  PMID: 23936052 RESULT

• 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.

  PMID: 25206941 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacterial cultures

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

Limitations and Caveats

Publication of results: "High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085889

Results Point of Contact

• Title: Arne Søraas, PhD
• Organization: Vestre Viken Hospital Trust

arne@meg.no

+4790652904

Study Officials

• Pål A Jenum, PhD

  Vestre Viken Hospital Trust

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: February 1, 2009
• Primary Completion: December 1, 2014
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-10