Management of Urinary Tract Infections in Primary Care Facilities.

Study Overview
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Brief Summary
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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.

Official Title
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Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Other: Delegation form


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delegation form<br> | Other: Delegation form<br>* 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.<br>|
| Active Comparator: Regular doctor's consultation<br> | Other: Delegation form<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 10 days after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary tract infection, Cystitis, Bacteruria