Management of Urinary Tract Infections in Primary Care Facilities.

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132131
• Other study ID #: 2010/486
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2010
• Last updated: February 1, 2012
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Norway	Legevakten i Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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	Yes