2024-512595-35-00招募中3 期
RETRAIN - 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.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- 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
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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
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
次要结局
- Number of hospital admissions for sepsis with a urinary tract origin at M12 and M24 (compared with M12)
- Number of symptomatic urinary tract infections - febrile and non-febrile - at M12 and M24 (compared with M12)
- Number of febrile urinary tract infections at M12 and M24 (compared with M12)
- Number of hospitalisations for urinary tract infections at M12 and M24 (compared with M12)
- Number of days spent on antibiotics at M12 and M24 (compared with M12) : for urinary indications / for any indication
- Number of days spent on antibiotics with a significant ecological impact at M12 and M24 (compared with M12)
- Number of courses of antibiotics for urinary indications at M12 and M24 (compared to M12)
- Number of courses of antibiotics, whatever the indication, at M12 and M24 (compared with M12).
- Quality of life score assessed at M0, M6 and M12, M18 and M24, using the Qualiveen questionnaire.
- 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
研究者
Chef de projets
Scientific
Centre Hospitalier Universitaire De Dijon
研究点 (10)
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