Urinary Tract Infections
Conditions
Brief 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.
Interventions
DRUGMEE-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.
OTHERPlacebo
Placebo
Sponsors
Theodor Bilharz Research Institute
The Cairo Kidney Center
Helwan University
Zagazig University
Dr. Ahmed Ismail
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response status | 5-7 days after completion of treatment | Clinical cure (disappearance of symptoms and signs) and microbiological cure (negative urine culture), 5-7 days after completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incomplete response status | 5-7 days after completion of treatment | Clinical cure (disappearance of symptoms and signs) with positive bacterial culture, 5-7 days after completion of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| - Failure status | 5-7 days after completion of treatment | No clinical response, 5- days after starting of treatment. |
| Recurrence | 60 ±10 days from the first day of the study drug administration | 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. |
Countries
Egypt
Outcome results
None listed