A Phase 2 interventional study of MEE-HU Medicus and Placebo in Urinary Tract Infections, sponsored by Dr. Ahmed Ismail. Active, not recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Dr. Ahmed Ismail · Phase 2, Interventional, and Treatment
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).
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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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.
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
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
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
Complete response status
Clinical cure (disappearance of symptoms and signs) and microbiological cure (negative urine culture), 5-7 days after completion of treatment.
Time frame: 5-7 days after completion of treatment
Incomplete response status
Clinical cure (disappearance of symptoms and signs) with positive bacterial culture, 5-7 days after completion of treatment.
Time frame: 5-7 days after completion of treatment
- Failure status
No clinical response, 5- days after starting of treatment.
Time frame: 5-7 days after completion of treatment
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.
Time frame: 60 ±10 days from the first day of the study drug administration
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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