Urinary Tract InfectionESCAPENCT01838213
Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients
An observational study of Urinary Tract Infection and Infection Due to ESBL Bacteria, run by Vestre Viken Hospital Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Infection Due to ESBL Bacteria, Environmental Contamination of ESBL
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients >=18 of age with a urine culture yielding E. coli or K. pneumoniae >10.000 colony forming units/mL.
Who cannot join
- 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.
About this study
Official title: Extended Spectrum Beta-lactamases - Treatment, Carriage, Environmental Dissemination And Population Epidemiology
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
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after initiation of treatment
Secondary outcomes (1)
Subjective Outcome
A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, University Hospital of North Norway, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Pål A Jenum, PhD, Study director, Vestre Viken Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838213
- Sponsor's protocol ID
- REK S-08901b
- Acronym
- ESCAPE
- Status last verified
- Oct 2015
- First submitted
- 18 Apr 2013
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24454943Soraas 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.
PubMed 23936052Soraas 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.
PubMed 25206941
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Spectrum Beta-lactamases - Treatment, Carriage, Environmental Dissemination And Population Epidemiology
- ClinicalTrials.gov ID
- NCT01838213
- Acronym / sponsor ID
- ESCAPE / REK S-08901b
- Conditions
- Urinary Tract Infection, Infection Due to ESBL Bacteria, Environmental Contamination of ESBL
- Keywords
- Urinary tract infection, ESBL, treatment, carriage, risk factors, water contamination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Helse Sor-Ost, University Hospital of North Norway, University of Oslo
- Study start
- Feb 2009
- Primary completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients >=18 of age with a urine culture yielding E. coli or K. pneumoniae >10.000 colony forming units/mL.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Failure
Time frame: 14 days after initiation of treatment
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.
1 secondary outcome
Subjective Outcome
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24454943Soraas 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.
- Results publication: PubMed 23936052Soraas 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.
- Results publication: PubMed 25206941Soraas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål A Jenum, PhD study director
Vestre Viken Hospital Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection and Infection Due to ESBL Bacteria, run by Vestre Viken Hospital Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure (time frame: 14 days after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838213, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.