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Management of Urinary Tract Infections in Primary Care Facilities.

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ClinicalTrials.gov Identifier: NCT01132131
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Marianne Bollestad, University of Oslo

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infection Other: Delegation form Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
Study Start Date : August 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Delegation form Other: Delegation form
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.
Active Comparator: Regular doctor's consultation Other: Delegation form
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 Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132131


Locations
Norway
Legevakten i Oslo
Oslo, Norway, 0182
Sponsors and Collaborators
University of Oslo
Investigators
Study Director: Morten Lindbaek, Md PhD University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marianne Bollestad, Md, University of Oslo
ClinicalTrials.gov Identifier: NCT01132131     History of Changes
Other Study ID Numbers: 2010/486
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Marianne Bollestad, University of Oslo:
Urinary tract infection
Cystitis
Bacteruria

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases