Management of Urinary Tract Infections in Primary Care Facilities.

NCT ID: NCT01132131

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delegation form

Group Type: ACTIVE_COMPARATOR

Delegation form

Intervention Type: 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.

Regular doctor's consultation

Group Type: ACTIVE_COMPARATOR

Delegation form

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Marianne Bollestad

Md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Lindbaek, Md PhD

Role: STUDY_DIRECTOR

University of Oslo

Locations

Legevakten i Oslo

Oslo, Oslo County, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 25961367 (View on PubMed)

Other Identifiers

2010/486

Identifier Type: -

Identifier Source: org_study_id