Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3 days (control intervention). Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients. The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment (control intervention) in terms of symptom resolution.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Clinic for Infectious Diseases, University Hospital Bern, Switzerland; University of Bern
• Treatments: Diclofenac; Fosfomycin; Norfloxacin

Criteria

Inclusion Criteria:

• Female

• Age between 18 and 70 years

• Written informed consent

• At least one typical symptom of acute, lower urinary tract infection out of dysuria, frequency, macrohaematuria, cloudy or smelly urine or self-diagnosed cystitis

• A urine dipstick test should be indicative of UTI by positive nitrite or leucocyturia

Exclusion Criteria

• Duration of UTI symptoms for more than 7 days before physician's visit

• Clinical signs of invasiveness such as fever (axillary body temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting

• Known or suspicion of anatomical or functional abnormality of the urinary tract

• Vaginal symptoms: discharge, irritation

• Diabetes mellitus

• Immunosuppression (e.g. prednisone equivalent >10mg per day for >14 days, chemotherapy, radiotherapy, immunomodulators, HIV infection, neutropenia)

• Any other serious comorbidity as judged by the treating physician

• Bladder catheter in situ or during the past 30 days

• Pregnancy

• Recurrent urinary tract infection (more than 3 infections during the last 12 months)

• Antibiotic treatment during the last 4 weeks

• Hypersensitivity to one of the study medications

• Psychiatric illness or dementia

• Unable to communicate in German or French language

• Documented coagulopathy (including therapy with coumarine derivatives) or documented history of gastric or duodenal ulcer disease

• Documented renal insufficiency grade III or higher (calculated GFR <60) or known congestive heart failure (NYHA III or higher)