Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Sep 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called OM-89 to see if it can help reduce the number of urinary tract infections (UTIs) in people with a neurogenic bladder, which is a bladder condition often caused by spinal cord injuries. UTIs are a common problem for these patients, leading to multiple hospital visits and increased use of antibiotics, which can create drug-resistant bacteria. The goal of the study is to determine if OM-89 can help prevent these infections without relying as heavily on antibiotics.

To be eligible for the trial, participants must be at least 18 years old, have a stabilized neurogenic bladder for over two years, and use a method called clean intermittent catheterization (CIC) regularly. They should have experienced at least six UTI treatments with antibiotics in the past year. If someone joins the study, they will receive either OM-89 or a placebo (a treatment with no active ingredients) and will be monitored to see how well the treatment works in preventing infections. Participants will have the opportunity to contribute to important research that could benefit many others facing similar health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Person who has given written consent
• • Patient aged 18 years or older
• • Patient with a stabilised neurogenic bladder following spinal cord injury for more than 2 years and who has undergone a urodynamic examination in the last 2 years.
• • Patients using CIC (5 to 6 per day)
• • 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)
• • Patients with a negative urine culture at the screening visit or treated with antibiotics for urinary decontamination prior to randomisation.
• Exclusion Criteria:
• • Person who is not affiliated with the national health insurance system
• • Person subject to a measure of legal protection (guardianship, tutorship)
• • Person subject to a court order
• • Adults unable to express consent
• • Patients using a urinary drainage method other than CIC
• • Patients with urinary lithiasis at the time of inclusion (assessed by ultrasound / scanner in the previous year as part of routine management)
• • Presence of an endo-urinary device (urinary prosthesis, ureteral stent)
• • Enterocystoplasty or irradiated bladder (past or present)
• • Known allergy or previous intolerance to the active substance or one of the excipients of OM-89 or placebo
• • Patient treated with bacterial lysates (including OM-89) in the 6 months prior to randomisation
• • Unable or unwilling to stop prophylactic antibiotic therapy prior to randomisation
• • Patient with a known malignant tumour or neoplasia
• • Patient with an autoimmune disease
• • Patient treated with long-term or bolus corticosteroids, anti-CD20 and anti-rejection therapy in the 6 months prior to screening
• • Patient currently taking part in another study on an investigational device or drug, or who has received another investigational treatment in the 30 days prior to screening.
• • Patient unable to collect information in a daily diary.
• • Patient unable to understand follow-up by telephone.
• • Patients planning to move to another residence in the year following randomisation
• • 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.