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Safety and Efficacy of MEE-HU Medicus — (SEM)  

Urinary Tract Infections Clinical Trial

Official title:
Safety and Efficacy of an Investigational Medicinal Product "MEE-HU Medicus",in Combination With Antimicrobial, in Urinary Tract Infection A Randomized, Double Blind, Placebo Controlled, Multicenter Study (SEM)

Clinical Trial Summary

Primary objective: is evaluation of the investigational product's safety and evaluation of its effect, in combination with antimicrobial treatment, on urine culture (microbiological cure, no microbial growth on 24-48 hrs culture). The secondary objective: is evaluation of the investigational product's effect, in combination with antimicrobial treatment, on disease related symptoms (Clinical cure, disappearance of symptoms and signs).

Clinical Trial Description

Design: Randomized, Double blind, Placebo controlled multicenter study. Recurrent urinary tract infection patients will blindly receive MEE-HU Medicus, or matching placebo, orally, daily, for 10 days, adjunct to the empirical antibiotic. Population: Male and female patients over 18 years old diagnosed with recurrent urinary tract infection. Sample Size: 200 patients, 100 from each center. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05023395
Study type Interventional
Source Heliopolis University
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 23, 2021
Completion date May 11, 2024
View Details
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