Management of Urinary Tract Infections in Primary Care Facilities.
Primary Purpose
Urinary Tract Infection
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Delegation form
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring Urinary tract infection, Cystitis, Bacteruria
Eligibility Criteria
Inclusion Criteria:
- Females 16-55 years
- Dysuria
- Increased frequency of urination
Exclusion Criteria:
- Pregnant
- Breastfeeding child < 1 month of age
- Diabetes
- Kidney disease
- Fever
- Poor general condition
- 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
Sites / Locations
- Legevakten i Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Delegation form
Regular doctor's consultation
Arm Description
Outcomes
Primary Outcome Measures
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.
Number of patients who are clinically and symptomatologically free of symptoms.
The antibiotic treatment will be of three days length
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01132131
Brief Title
Management of Urinary Tract Infections in Primary Care Facilities.
Official Title
Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Urinary tract infection, Cystitis, Bacteruria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
443 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delegation form
Arm Type
Active Comparator
Arm Title
Regular doctor's consultation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Delegation form
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection.
Description
The antibiotic treatment given will be of three days length.
Time Frame
6 days after start of treatment.
Title
Number of patients who are clinically and symptomatologically free of symptoms.
Description
The antibiotic treatment will be of three days length
Time Frame
10 days after start of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females 16-55 years
Dysuria
Increased frequency of urination
Exclusion Criteria:
Pregnant
Breastfeeding child < 1 month of age
Diabetes
Kidney disease
Fever
Poor general condition
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Lindbaek, Md PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Legevakten i Oslo
City
Oslo
ZIP/Postal Code
0182
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25961367
Citation
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.
Results Reference
derived
Learn more about this trial
Management of Urinary Tract Infections in Primary Care Facilities.
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