NCT01488955

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

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - a Comparative Effectiveness Study in General Practice (ICUTI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Ibuprofen	400 mg oral once a day from day 0 for 3 days
DRUG	Fosfomycin-Trometamol	8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-02-01
• Completion: 2014-07-01
• First posted: 2011-12-08
• Last updated: 2014-08-08

Locations

2 sites across 1 country: Germany