Urinary Tract InfectionPhase 4NCT01132131
Management of Urinary Tract Infections in Primary Care Facilities.
A Phase 4 study testing Delegation form in people with Urinary Tract Infection, run by University of Oslo at 1 site in Norway.
Trial summary
The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify patients who qualify for treatment of acute cystitis by the use of a delegation form. The aim of the study is to evaluate this practice, the primary objective being to evaluate if in a selected patient group the treatment outcome… Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Delegation form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to Dec 2011
- Phase
- Phase 4
- 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 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females 16-55 years
- Dysuria
- Increased frequency of urination
Who cannot join
- Pregnant
- Breastfeeding child < 1 month of age
- Diabetes
- Kidney disease
- Fever
- Poor general condition
Show all 16Show fewer
- Backpain
- Abdominal pain
- Increased amount of vaginal secretions
- Vaginal itching or pain
- Urinary tract infection in the last four weeks
- Use of urinary catheter in the last four weeks
- Symptoms lasting more than seven days
- Ongoing antibiotic treatment
- Allergy to penicillin
- Use of the medicine Probecid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify patients who qualify for treatment of acute cystitis by the use of a delegation form.
The aim of the study is to evaluate this practice, the primary objective being to evaluate if in a selected patient group the treatment outcome after identifying patients with probable acute cystitis by delegation form will be as good or better than the treatment received after a regular doctor's consultation.
The planned study will also investigate which symptoms, signs and laboratory findings that coincide with significant bacteruria.
The reference standard will be a microbiological culture of every patients urine.
- Conditions
- Urinary Tract Infection
- Being tested
- Delegation form
- Keywords
- Urinary tract infection, Cystitis, Bacteruria
- Medical subject headings
- Urinary Tract Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delegation formOther
The study aims to compare the use of a delegation form to identify patient's who qualify for antibiotic treatment for suspected acute cystitis with a regular doctor's consultation. The key outcomes are lack of bacteruria and symptoms of UTI at followup times.
| Study group | Role | What they receive |
|---|---|---|
| Delegation form | Active comparator | Not described Receives: Other: Delegation form |
| Regular doctor's consultation | Active comparator | Not described Receives: Other: Delegation form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection.
The antibiotic treatment given will be of three days length.
Measured: 6 days after start of treatment.
Number of patients who are clinically and symptomatologically free of symptoms.
The antibiotic treatment will be of three days length
Measured: 10 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionDec 2011
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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- 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
- NCT01132131
- Sponsor's protocol ID
- 2010/486
- Status last verified
- Feb 2012
- First submitted
- 20 May 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bollestad M, Grude N, Lindbaek M. A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Scand J Prim Health Care. 2015 Jun;33(2):57-64. doi: 10.3109/02813432.2015.1041827. Epub 2015 May 11.
PubMed 25961367
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
- ClinicalTrials.gov ID
- NCT01132131
- Acronym / sponsor ID
- 2010/486
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary tract infection, Cystitis, Bacteruria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 May 2010 (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 Emergency Ward Center in Oslo has the last two years used a questionnaire to identify patients who qualify for treatment of acute cystitis by the use of a delegation form.
The aim of the study is to evaluate this practice, the primary objective being to evaluate if in a selected patient group the treatment outcome after identifying patients with probable acute cystitis by delegation form will be as good or better than the treatment received after a regular doctor's consultation.
The planned study will also investigate which symptoms, signs and laboratory findings that coincide with significant bacteruria.
The reference standard will be a microbiological culture of every patients urine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delegation form | Active comparator | Other: Delegation form |
| Regular doctor's consultation | Active comparator | Other: Delegation form |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Females 16-55 years
- Dysuria
- Increased frequency of urination
Key exclusion criteria (16 listed)
- Pregnant
- Breastfeeding child < 1 month of age
- Diabetes
- Kidney disease
- Fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delegation formThe study aims to compare the use of a delegation form to identify patient's who qualify for antibiotic treatment for suspected acute cystitis with a regular doctor's consultation. The key outcomes are lack of bacteruria and symptoms of UTI at followup times. | Other | Delegation form, Regular doctor's consultation |
Primary outcome
Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection.
Time frame: 6 days after start of treatment.
The antibiotic treatment given will be of three days length.
Number of patients who are clinically and symptomatologically free of symptoms.
Time frame: 10 days after start of treatment
The antibiotic treatment will be of three days length
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 2 Feb 2012.
- Derived from this study: PubMed 25961367Bollestad M, Grude N, Lindbaek M. A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Scand J Prim Health Care. 2015 Jun;33(2):57-64. doi: 10.3109/02813432.2015.1041827. Epub 2015 May 11.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Delegation form in people with Urinary Tract Infection, run by University of Oslo at 1 site 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 3 inclusion and 16 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 patients who are clinically and bacteriologically free of symptoms of urinary tract infection. (time frame: 6 days after start of treatment.). The study lists 2 primary outcomes in all. 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 NCT01132131, 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 2 Feb 2012.