Safety and Efficacy of MEE-HU Medicus

NCT05023395 | Active Not Recruiting Phase 2

• 1 other identifier: 00012020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incomplete response status

  5-7 days after completion of treatment

Other Outcomes (2)

• - Failure status

  5-7 days after completion of treatment

• Recurrence

  60 ±10 days from the first day of the study drug administration

Study Arms (2)

Investigational Medicinal Product

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

MEE-HU Medicus DRUG

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.

Investigational Medicinal Product

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Dr. Ahmed Ismail: lead
• Theodor Bilharz Research Institute: collaborator
• The Cairo Kidney Center: collaborator
• Helwan University: collaborator
• Zagazig University: collaborator

Study Sites (2)

Cairo Kidney Center

Cairo, Egypt

Location

Theodor Bilharz Research Institute

Giza, Egypt

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Research Director

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 26, 2021
• Study Start: October 23, 2021
• Primary Completion: March 24, 2024
• Study Completion: May 11, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)