Urinary Tract InfectionsNCT01531023
Treatment of Extended Spectrum Betalactamase Producing Bacteria Causing Urinary Tract Infections in General Practice
An observational study of Urinary Tract Infections, run by University of Oslo at 7 sites in Norway.
Trial summary
The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine sample cultures has been increasing over the past decades. The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of ESBL producing E. coli and K. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 168 participants
- Where
- 7 sitesNorway
- Study dates
- Apr 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected from all patients ages 16 and over who are diagnosed with an urinary tract infection where an ESBL producing bacteria (E. coli) is found. The urinary tract infection must be diagnosed and treated in a primary care setting.
Who may be able to join
- All patients were urinary sample taken in a primary care setting shows significant growth of ESBL producing E. coli.
- Above age 16.
Who cannot join
- Sample from patients in hospital care or living in nursing home facilities. Inability to understand and sign information leaflet.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Vestre Viken Hospital Trust
Bærum
University Hospital Akershus
Lørenskog
Unilabs
Skien
Helse Stavanger HF
Stavanger
Vestfold Hospital Trust
Tønsberg
University Hospital of North Norway
Tromsø
St Olavs Hospital
Trondheim
About this study
Official title: What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?
The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine sample cultures has been increasing over the past decades.
The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and microbiological outcome of the same group of bacteria treated with other antiinfectious agents.
Samples are gathered in primary care setting.
- Conditions
- Urinary Tract Infections
- Keywords
- Extended-Spectrum Beta-lactamase Producing Bacteria
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESBL producing E. coli bacteria | Group of patients with identified ESBL producing E.coli in a urine sample taken in a primary care setting. | |
| Non-ESBL E.coli urinary tract infection | E.coli bacteria found in the setting of a urinary tract infection in a primary care setting where ESBL producing bacteria are not found. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days until symptomatic resolution
Number of days from the start of treatment that the patient feels completely free of urinary tract symptoms Number of days after start of antibiotic treatment with mecillinam when the patient feels free of symptoms from the urinary tract
Measured: Two weeks after finishing the primary antibiotic treatment
Secondary outcomes (2)
Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment
Measured: Two weeks after end of initial treatment
Number of patients who received a second treatment regime in the follow-up period
Number of patients who received a secondary antibiotic treatment to obtain clinical cure.
Measured: 2 weeks after end of initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startApr 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Helse Stavanger HF, The Hospital of Vestfold, Vestre Viken Hospital Trust, University Hospital, Akershus, Unilabs
- Responsible party
- Principal investigator, Marianne Bollestad, University of Oslo
- Investigators
- Morten Lindbaek, Md PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531023
- Sponsor's protocol ID
- 2011/2214-3
- Status last verified
- Oct 2016
- First submitted
- 7 Feb 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bollestad M, Grude N, Solhaug S, Raffelsberger N, Handal N, Nilsen HS, Romstad MR, Emmert A, Tveten Y, Soraas A, Jenum PA, Jenum S, Moller-Stray J, Weme ET, Lindbaek M, Simonsen GS; (the Norwegian ESBL UTI study group). Clinical and bacteriological efficacy of pivmecillinam treatment for uncomplicated urinary tract infections caused by ESBL-producing Escherichia coli: a prospective, multicentre, observational cohort study. J Antimicrob Chemother. 2018 Sep 1;73(9):2503-2509. doi: 10.1093/jac/dky230.
PubMed 29982514
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Outcome of Treatment of Urinary Tract Infections Caused by Bacteria Producing Extended Spectrum Betalactamase in a Primary Care Setting?
- ClinicalTrials.gov ID
- NCT01531023
- Acronym / sponsor ID
- 2011/2214-3
- Conditions
- Urinary Tract Infections
- Keywords
- Extended-Spectrum Beta-lactamase Producing Bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- University Hospital of North Norway, St. Olavs Hospital, Helse Stavanger HF, The Hospital of Vestfold, Vestre Viken Hospital Trust, University Hospital, Akershus, Unilabs
- Study start
- Apr 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of extended spectrum beta-lactamase (ESBL) producing bacteria found in urine sample cultures has been increasing over the past decades.
The study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of ESBL producing E. coli and K. Pneumoni, as well as to observe the clinical and microbiological outcome of the same group of bacteria treated with other antiinfectious agents.
Samples are gathered in primary care setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESBL producing E. coli bacteria | – | –Group of patients with identified ESBL producing E.coli in a urine sample taken in a primary care setting. |
| Non-ESBL E.coli urinary tract infection | – | –E.coli bacteria found in the setting of a urinary tract infection in a primary care setting where ESBL producing bacteria are not found. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from all patients ages 16 and over who are diagnosed with an urinary tract infection where an ESBL producing bacteria (E. coli) is found. The urinary tract infection must be diagnosed and treated in a primary care setting.
Key inclusion criteria (2 listed)
- All patients were urinary sample taken in a primary care setting shows significant growth of ESBL producing E. coli.
- Above age 16.
Key exclusion criteria (1 listed)
- Sample from patients in hospital care or living in nursing home facilities. Inability to understand and sign information leaflet.
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
Number of days until symptomatic resolution
Time frame: Two weeks after finishing the primary antibiotic treatment
Number of days from the start of treatment that the patient feels completely free of urinary tract symptoms Number of days after start of antibiotic treatment with mecillinam when the patient feels free of symptoms from the urinary tract
2 secondary outcomes
Number of patients with ESBL producing bacteria detected in a urine sample taken two weeks after finishing initial treatment
Time frame: Two weeks after end of initial treatment
Number of patients who received a second treatment regime in the follow-up period
Time frame: 2 weeks after end of initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Derived from this study: PubMed 29982514Bollestad M, Grude N, Solhaug S, Raffelsberger N, Handal N, Nilsen HS, Romstad MR, Emmert A, Tveten Y, Soraas A, Jenum PA, Jenum S, Moller-Stray J, Weme ET, Lindbaek M, Simonsen GS; (the Norwegian ESBL UTI study group). Clinical and bacteriological efficacy of pivmecillinam treatment for uncomplicated urinary tract infections caused by ESBL-producing Escherichia coli: a prospective, multicentre, observational cohort study. J Antimicrob Chemother. 2018 Sep 1;73(9):2503-2509. doi: 10.1093/jac/dky230.
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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.
Morten Lindbaek, Md PhD study director
University of Oslo
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by University of Oslo at 7 sites in Norway.
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 2 inclusion and 1 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of days until symptomatic resolution (time frame: Two weeks after finishing the primary antibiotic 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 NCT01531023, which also lists 1 linked publication.
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 31 Oct 2016.