Evaluating OM-89 for reducing antibiotic use in urinary tract infections for patients with neurogenic bladder
Multicentre Randomised Double-blind Superiority Trial With a Roll-over Phase to 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
This study is testing if a new non-antibiotic treatment called OM-89 can help people with neurogenic bladder reduce their urinary tract infections and the need for antibiotics.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06588010 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the efficacy of OM-89, a non-antibiotic prophylactic treatment, compared to a placebo in patients with neurogenic bladder who frequently experience recurrent urinary tract infections (UTIs). The study focuses on individuals who have been using clean intermittent catheterization (CIC) and have a history of multiple antibiotic treatments for UTIs. By reducing antibiotic consumption, the trial aims to address the growing concern of multidrug-resistant bacteria and improve patient outcomes. Participants will be monitored for UTI recurrence and overall health improvements over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a stabilized neurogenic bladder who have undergone urodynamic examination and have a history of recurrent UTIs requiring multiple antibiotic treatments.
Not a fit: Patients who use urinary drainage methods other than clean intermittent catheterization or those with urinary lithiasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for antibiotics in patients with neurogenic bladder, lowering the risk of antibiotic resistance and improving quality of life.
How similar studies have performed: Other studies exploring non-antibiotic prophylaxis for UTIs have shown promise, indicating that this approach may be effective in reducing antibiotic use.
Eligibility criteria
Show full inclusion / exclusion 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 thaht has not progressed 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 between screening visit and randomisation 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 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) * 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 requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.) * 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 related to urinary tract infections, 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.
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Lionel PIROTH
- Email: lionel.piroth@chu-dijon.fr
- Phone: 0380293305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.