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Safety and Efficacy of MEE-HU Medicus ((SEM))

Primary Purpose

Urinary Tract Infections

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
MEE-HU Medicus
Placebo
Sponsored by
Dr. Ahmed Ismail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo Kidney Center
  • Theodor Bilharz Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational Medicinal Product

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Complete response status
Clinical cure (disappearance of symptoms and signs) and microbiological cure (negative urine culture), 5-7 days after completion of treatment.

Secondary Outcome Measures

Incomplete response status
Clinical cure (disappearance of symptoms and signs) with positive bacterial culture, 5-7 days after completion of treatment.

Full Information

First Posted
August 23, 2021
Last Updated
October 11, 2021
Sponsor
Dr. Ahmed Ismail
Collaborators
Theodor Bilharz Research Institute, Cairo Kidney Center
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1. Study Identification

Unique Protocol Identification Number
NCT05023395
Brief Title
Safety and Efficacy of MEE-HU Medicus
Acronym
(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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2021 (Anticipated)
Primary Completion Date
October 11, 2023 (Anticipated)
Study Completion Date
October 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Ahmed Ismail
Collaborators
Theodor Bilharz Research Institute, Cairo Kidney Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Medicinal Product
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MEE-HU Medicus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Complete response status
Description
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
Secondary Outcome Measure Information:
Title
Incomplete response status
Description
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
Other Pre-specified Outcome Measures:
Title
- Failure status
Description
No clinical response, 5- days after starting of treatment.
Time Frame
5-7 days after completion of treatment
Title
Recurrence
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed I Ismail
Phone
01223999112
Email
ahmed.ismail@hu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan M Asy
Email
hanan.asy@hu.edu.eg
Facility Information:
Facility Name
Cairo Kidney Center
City
Cairo
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Theodor Bilharz Research Institute
City
Giza
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of MEE-HU Medicus

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