Sponsor study identifier
observational
760
0 countries
N/A
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 18, 2013
Actual (reported)April 23, 2013
Actual (reported)December 2014
Actual (reported)November 23, 2015
Actual (reported)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
Subjective Outcome
14 days
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.
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.
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.
Bacterial cultures
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
Pål A Jenum, PhD
Vestre Viken Hospital Trust
760 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2013
First Posted
April 23, 2013
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Carriage of ESBL Producing Bacteria
up to 3 years
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2014
Actual (reported)Last Updated
November 23, 2015
Results First Posted
November 23, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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