E.COLI POLYSACCHARIDE for Neurogenic bladder | Recurrent urinary tract infections

Inclusion criteria

• {"criterion_text":"- Person who has given written consent\n- Patient aged 18 years or older\n- Patient with a stabilised neurogenic bladder following spinal cord injury that has not progressed for more than 2 years and who has undergone a urodynamic examination in the last 2 years.\n- Patients using CIC (5 to 6 per day)\n- Patients who have received at least 6 courses of antibiotic treatment for UTIs in the 12 months prior to screening (whether for curative or prophylactic reasons)\n- Patients with a negative urine culture between screening visit and randomisation or treated with antibiotics for urinary decontamination prior to randomisation."}

Exclusion criteria

• {"criterion_text":"- Person who is not affiliated with the national health insurance system\n- Person subject to a measure of legal protection (guardianship, tutorship)\n- Person subject to a court order\n- Adults unable to express consent\n- Patients using a urinary drainage method other than CIC\n- Patients with urinary lithiasis at the time of inclusion (assessed by renal imaging in the previous year as part of routine management for patients with a history(s) of lithiasis or within 3 years for patients with no history)\n- Presence of an endo-urinary device (urinary prosthesis, ureteral stent)\n- Enterocystoplasty or irradiated bladder (past or present)\n- Known allergy or previous intolerance to the active substance or one of the excipients of OM-89 or placebo\n- Patient unable to collect information in a daily diary.\n- Patient unable to understand follow-up by telephone.\n- Patient treated with bacterial lysates (including OM-89) in the 6 months prior to randomisation\n- Unable or unwilling to stop prophylactic antibiotic therapy prior to randomisation\n- Patient with a known malignant tumour or neoplasia\n- Patient with an autoimmune disease\n- Patient treated with long-term or bolus corticosteroids, anti-CD20 and anti-rejection therapy in the 6 months prior to screening\n- Patient currently taking part in another study on an investigational device or drug related to urinary tract infections, or who has received another investigational treatment in the 30 days prior to screening.\n- Patients planning to move to another residence in the year following randomisation\n- Non-menopausal women who are not surgically sterile (bilateral oophorectomy or hysterectomy) AND pregnant, breast-feeding who are declare that they are planning to conceive at inclusion, or not using effective* contraception. * Contraceptive methods considered to be highly effective birth control methods when used consistently and correctly, with a failure rate of less than 1%. •\tCombined hormones (containing estrogen and progestin) contraception associated with ovulation inhibition: ●oral ●intravaginal ●transdermal •Progestin-only hormonal contraception combined with ovulation inhibition: ●oral ●injectable ●implantable •Intrauterine device (IUD) •Intrauterine hormone delivery system •Bilateral tubal occlusion •Vasectomized partner\n- Patient requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.)"}

Primary endpoints

• {"endpoint_text":"- Number of antibiotic treatment episodes for UTIsper person-days at risk during the first year. An episode of treatment is defined as a single prescription of a given antibiotic, regardless of its intended duration (curative or prophylactic). A day at risk is defined as a follow-up day without antibiotic treatment","definition_or_measurement_approach":"An episode of treatment is defined as a single prescription of a given antibiotic, regardless of intended duration (curative or prophylactic). A day at risk is defined as a follow-up day without antibiotic treatment; incidence is calculated as episodes per person-days at risk during the first year."}

Secondary endpoints

• {"endpoint_text":"- Number of symptomatic urinary tract infections - febrile and non-febrile - at M12 and M24 (compared with M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of febrile urinary tract infections at M12 and M24 (compared with M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of hospitalisations for urinary tract infections at M12 and M24 (compared with M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of hospital admissions for sepsis with a urinary tract origin at M12 and M24 (compared with M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of days spent on antibiotics at M12 and M24 (compared with M12) : for urinary indications / for any indication","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of days spent on antibiotics with a significant ecological impact at M12 and M24 (compared with M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of courses of antibiotics for urinary indications at M12 and M24 (compared to M12)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of courses of antibiotics, whatever the indication, at M12 and M24 (compared with M12).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life score assessed at M0, M6 and M12, M18 and M24, using the Qualiveen questionnaire.","definition_or_measurement_approach":"Measured using the Qualiveen questionnaire at scheduled timepoints M0, M6, M12, M18 and M24."}
• {"endpoint_text":"- Number of adverse events (AEs) and relationship to OM-89 : Grade 1 mild AE - Grade 2 Moderate AE - Grade 3 Severe AE - Grade 4 Life-threatening or disabling AEs - Grade 5 AE-related death","definition_or_measurement_approach":"AEs to be recorded and graded by severity (Grade 1 to Grade 5) and assessed for relationship to OM-89."}

France

Earliest CTIS Part Ii Submission Date

23-07-2024

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

597

Number Of Sites

12

Number Of Participants

110

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France