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| Name | Class |
|---|---|
| Helse Sor-Ost | OTHER_GOV |
| University Hospital of North Norway | OTHER |
| University of Oslo | OTHER |
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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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Outcome | A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| PÃ¥l A Jenum, PhD | Vestre Viken Hospital Trust | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24454943 | Result | 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. | |
| 23936052 | 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. |
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Patients with any type of CA-UTI caused by ESBL-producing or non-ESBL producing E. coli and receiving empirical treatment were included in the study. Data on treatment outcome were obtained and possible associations between outcome and mecillinam treatment, ESBL-status and other variables were investigated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With UTI Caused by Extended-spectrum β-lactamase-prod | Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli |
| FG001 | Patients With UTI Caused by Non-ESBL-producing E. Coli | Patients with UTI caused by non-ESBL-producing E. coli |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With UTI Caused by Extended-spectrum β-lactamase-prod | Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli |
| BG001 | Patients With UTI Caused by Non-ESBL-producing E. Coli |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients that did receice pivmecillinam. | Posted | Number | Treatment success | 14 days after initiation of treatment |
|
Participants in the study were treated for their urinary tract infection as part of routine and adverse events were not recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With UTI Caused by Extended-spectrum β-lactamase-prod | Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arne Søraas, PhD | Vestre Viken Hospital Trust | +4790652904 | arne@meg.no |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Bacterial cultures
| 25206941 | 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. |
Patients with UTI caused by non-ESBL-producing E. coli
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Patients With UTI Caused by Non-ESBL-producing E. Coli | Patients with UTI caused by non-ESBL-producing E. coli |
|
|
| Secondary | Subjective Outcome | A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded. | Not Posted | 14 days |
| Other Pre-specified | 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. | Not Posted | up to 3 years |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Patients With UTI Caused by Non-ESBL-producing E. Coli | Patients with UTI caused by non-ESBL-producing E. coli | 0 | 262 | 0 | 262 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |