drugset / Trial / NCT01039545

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

NCT01039545

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-02
Primary completion
2014-12
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 75 mg
Comparator Norfloxacin Small molecule 400 mg
Background Fosfomycin Small molecule 3 g