Safety and Efficacy of MEE-HU Medicus

Urinary Tract Infections Clinical Trial

— (SEM)  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05023395
• Other study ID #: 00012020
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 23, 2021
• Est. completion date: May 11, 2024

Study information

• Verified date: February 2024
• Source: Heliopolis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 11, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Male and female patients over 18 years old - Symptomatic urinary tract infection (pain, dysuria, frequency, urgency, fever) confirmed by urine analysis (Pyuria, which is defined as urine WBC >10). - Negative pregnancy test and absence of vaginal discharge. - Recurrent urinary tract infection 2 times or more in the last 6 months or 3time or more in the last year. - Signed informed consent.

Exclusion Criteria Patients unable or unwilling to provide their free consent to participate in the study - Patients known or suspected to be hypersensitive to medications that will be used in the study. - Simultaneous participation in other studies. - Patients on palliative care, terminal illness. - Evidence of acute or chronic prostatitis or pyelonephritis. - History of antimicrobial use in the last 72 hrs. - Patients with renal transplantation.

Related Conditions & MeSH terms

• Infections
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo Kidney Center	Cairo
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (5)

Lead Sponsor	Collaborator
Dr. Ahmed Ismail	Helwan University, The Cairo Kidney Center, Theodor Bilharz Research Institute, Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	- Failure status	No clinical response, 5- days after starting of treatment.	5-7 days after completion of treatment
Other	Recurrence	Development of new symptoms of urinary tract infection in patients with previously clinical and microbiological cure plus positive urine cultures; 60 ±10 days from the first day of the study drug administration.	60 ±10 days from the first day of the study drug administration
Primary	Complete response status	Clinical cure (disappearance of symptoms and signs) and microbiological cure (negative urine culture), 5-7 days after completion of treatment.	5-7 days after completion of treatment
Secondary	Incomplete response status	Clinical cure (disappearance of symptoms and signs) with positive bacterial culture, 5-7 days after completion of treatment.	5-7 days after completion of treatment