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

May 20, 2010
February 1, 2012
August 2010
December 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01132131 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Management of Urinary Tract Infections in Primary Care Facilities.
Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Tract Infection
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: Delegation form
    Intervention: Other: Delegation form
  • Active Comparator: Regular doctor's consultation
    Intervention: Other: Delegation form
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
443
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
16 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01132131
2010/486
No
Marianne Bollestad, University of Oslo
University of Oslo
Not Provided
Study Director: Morten Lindbaek, Md PhD University of Oslo
University of Oslo
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP