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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014