drugset / Trial / NCT01488955

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI

NCT01488955 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced. Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.

Timeline

Start
2012-02
Primary completion
2014-02
Completion
2014-07

Outcome

Mixed primary results

paper The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. PMID 26698878 ↗

paper The 248 women in the ibuprofen group received significantly fewer course of antibiotics, had a significantly higher total burden of symptoms, and more had pyelonephritis. PMID 26698878 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosfomycin Small molecule 3 g Oral
Subject Ibuprofen Small molecule 400 mg Oral