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Multicentre randomised double-blind superiority trial with a roll-over phase to evaluate the efficacy of OM-89 vs placebo in reducing antibiotic consumption associated with the treatment of urinary tract infections in patients with a neurological bladder.
EU CTIS ID: 2024-512595-35-00
What this study is testing
To compare the incidence rate of courses of antibiotics for urinary tract infections (administered to treat or prevent urinary tract infections) between M0 and M12 in patients with a spinal cord injury and a stabilised neurogenic bladder and on CIC, receiving either OM-89 (experimental group) or placebo (control group).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Person who has given written consent
- Patient aged 18 years or older
- 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.
- 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.
You likely can't join if
- Person who is not affiliated with the national health insurance system
- Patient unable to collect information in a daily diary.
- Patient unable to understand follow-up by telephone.
- 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
See the full eligibility criteria
- Person who has given written consent
- Patient aged 18 years or older
- 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.
- 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.
- Person who is not affiliated with the national health insurance system
- Patient unable to collect information in a daily diary.
- Patient unable to understand follow-up by telephone.
- 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.
- 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. * Contraceptive methods considered to be highly effective birth control methods when used consistently and correctly, with a failure rate of less than 1%. • Combined 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
- Person subject to a measure of legal protection (guardianship, tutorship)
- Patient requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.