Management of Urinary Tract Infections in Primary Care Facilities.

University of Oslo

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection

Treatments: Other: Delegation form

Study type: Interventional

Funder types: Other

Identifiers

NCT01132131

2010/486

Details and patient eligibility

About

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.

Enrollment: 443 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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443 participants in 2 patient groups

Delegation form

Active Comparator group

Treatment:

Other: Delegation form

Regular doctor's consultation

Active Comparator group

Treatment:

Other: Delegation form