Management of Urinary Tract Infections in Primary Care Facilities.

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01132131
• Collaborator: (none)
• Enrollment: 443
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 27.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Other: Delegation form	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 443 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection. [6 days after start of treatment.]

   The antibiotic treatment given will be of three days length.

2. Number of patients who are clinically and symptomatologically free of symptoms. [10 days after start of treatment]

   The antibiotic treatment will be of three days length

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Legevakten i Oslo	Oslo		Norway	0182

Sponsors and Collaborators

• University of Oslo

Investigators

• Study Director: Morten Lindbaek, Md PhD, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marianne Bollestad, Md, University of Oslo
• ClinicalTrials.gov Identifier: NCT01132131
• Other Study ID Numbers: 2010/486
• First Posted: May 27, 2010
• Last Update Posted: Feb 2, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Marianne Bollestad, Md, University of Oslo: Urinary tract infection; Cystitis; Bacteruria
• Additional relevant MeSH terms: Infections; Urinary Tract Infections

Study Results

No Results Posted as of Feb 2, 2012