2024-512595-35-00
Recruiting
Phase 3
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.
Centre Hospitalier Universitaire De Dijon10 sites in 1 country110 target enrollmentStarted: August 19, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 110
- Locations
- 10
- Primary Endpoint
- 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
Overview
Brief Summary
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).
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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
Investigators
Chef de projets
Scientific
Centre Hospitalier Universitaire De Dijon
Study Sites (10)
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