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Management of Urinary Tract Infections in Primary Care Facilities.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marianne Bollestad, University of Oslo
ClinicalTrials.gov Identifier:
NCT01132131
First received: May 20, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Urinary Tract Infection
 Other: Delegation form
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection. [ Time Frame: 6 days after start of treatment. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The antibiotic treatment will be of three days length


Enrollment: 443
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Marianne Bollestad, Md, University of Oslo
ClinicalTrials.gov Identifier: NCT01132131     History of Changes
Other Study ID Numbers: 2010/486
Study First Received: May 20, 2010
Last Updated: February 1, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013