Management of Urinary Tract Infections in Primary Care Facilities.

NCT01132131 | Completed Phase 4

• 1 other identifier: 2010/486
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

Urinary tract infection; Cystitis; Bacteruria

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (2)

Delegation form

ACTIVE COMPARATOR

Other: Delegation form

Regular doctor's consultation

ACTIVE COMPARATOR

Other: Delegation form

Interventions

Delegation form OTHER

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.

Delegation form; Regular doctor's consultation

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females 16-55 years
• Dysuria
• Increased frequency of urination

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Legevakten i Oslo

Oslo, Oslo County, 0182, Norway

Location

Related Publications (1)

• Bollestad M, Grude N, Lindbaek M. A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Scand J Prim Health Care. 2015 Jun;33(2):57-64. doi: 10.3109/02813432.2015.1041827. Epub 2015 May 11.

  PMID: 25961367 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Cystitis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases

Study Officials

• Morten Lindbaek, Md PhD

  University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 27, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

NO (1)