Safety and Efficacy of MEE-HU Medicus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: MEE-HU Medicus
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Medicinal Product<br>Patients will be assigned to receive oral MEE-HU Medicus with the empirical antibiotic. A study pharmacist will prepare visually matched packages in identical, sequentially numbered treatment packs according to a previously done computer-generated randomization list, using block randomization with variable blocks of length 4 and 6. To be dispended, in sequential order, as participants will be recruited. All participants, enrolling physicians and investigators will be blinded to the treatment allocations. Attending physicians will be responsible for enrolling the participants and ensuring that the study medications are given from the appropriate treatment pack. Selection bias is minimized by randomization, while performance bias is minimized by blinding. | Drug: MEE-HU Medicus<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Patients will be assigned to receive oral matching placebo with the empirical antibiotic. A study pharmacist will prepare visually matched packages in identical, sequentially numbered treatment packs according to a previously done computer-generated randomization list, using block randomization with variable blocks of length 4 and 6. To be dispended, in sequential order, as participants will be recruited. All participants, enrolling physicians and investigators will be blinded to the treatment allocations. Attending physicians will be responsible for enrolling the participants and ensuring that the study medications are given from the appropriate treatment pack. Selection bias is minimized by randomization, while performance bias is minimized by blinding. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |