Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2021-10-23
2024-05-11
Brief Summary
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Detailed Description
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Population: Male and female patients over 18 years old diagnosed with recurrent urinary tract infection. Sample Size: 200 patients, 100 from each center.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Investigational Medicinal Product
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.
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.
Placebo
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.
Placebo
Placebo
Interventions
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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.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Theodor Bilharz Research Institute
OTHER
The Cairo Kidney Center
UNKNOWN
Helwan University
OTHER
Zagazig University
OTHER_GOV
Dr. Ahmed Ismail
OTHER
Responsible Party
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Dr. Ahmed Ismail
Medical Research Director
Locations
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Cairo Kidney Center
Cairo, , Egypt
Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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Other Identifiers
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00012020
Identifier Type: -
Identifier Source: org_study_id
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