NCT02639520

Efficacy of CLR Compared to Fosfomycin Trometamol in Acute Lower uUTIs

A Double-blind, Controlled, Parallel-group, Randomized, Multicenter Clinical Trial to Assess the Efficacy and Safety of a Herbal Drug Containing Centaury, Lovage Root and Rosemary Leaf (CLR) in Comparison to Fosfomycin Trometamol for the Treatment of Acute Lower Uncomplicated Urinary Tract Infections (uUTIs) in Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 659 (actual)
• Sponsor: Bionorica SE · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by the proportion of patients who received an additional antibiotic treatment for acute lower uUTIs during the trial.

Detailed description

The trial is designed as a comparison of two different modes of action in order to look for alternatives to antibiotic treatment of uncomplicated UTIs. Treatment with CLR is a nonantibiotic therapy and is compared to an antibiotic treatment. Thus, the trial aim is to reduce antibiotics use and moreover to reduce the pressure of developing bacterial resistance against antibiotics due to widespread use, which is an additional advantage of the CLR therapy. The trial results are expected to demonstrate that antibiotic prescriptions in women for treatment of lower uUTIs can be reduced by an alternative and safe non-antibiotic treatment.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Canephron® N	2 tablets 3 times a day for 7 days
DRUG	Fosfomycin trometamol	1 sachet of 8 g of granules; one single dose on Day 1
DRUG	Canephron® N-placebo	2 tablets 3 times a day for 7 days
DRUG	Fosfomycin trometamol-placebo	1 sachet of 8 g of granules; one single dose on Day 1

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-29
• First posted: 2015-12-24
• Last updated: 2017-07-28

Locations

1 site across 1 country: Germany