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OpenTrials
Completed

NCT Number: NCT01132131

Management of Urinary Tract Infections in Primary Care Facilities.

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.

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Key information

Age range

16 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Legevakten i Oslo

Oslo, 0182, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection.

    Time frame: 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.

    Time frame: 10 days after start of treatment

    The antibiotic treatment will be of three days length

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 27, 2010
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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