NCT05023395

Safety and Efficacy of MEE-HU Medicus

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dr. Ahmed Ismail · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	MEE-HU Medicus	This investigational medicinal product (MEE-HU Medicus) is a patented mixture of amino acids and pentose sugar. The mixture according to the invention in particular is suitable as medicine for resistance-breaking of antibiotic resistances of pathogens, in particular for resistance-breaking of multiple antibiotic resistances, a method for decreasing bacterial resistance to antibiotics.
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-10-23
• Primary completion: 2024-03-24
• Completion: 2024-05-11
• First posted: 2021-08-26
• Last updated: 2024-02-08

Locations

2 sites across 1 country: Egypt