Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588010
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRAIN
Brief Summary:
Recurrent urinary tract infections UTIs in patients with a neurogenic bladder using clean intermittent catheterization CIC are a major problem In this population urinary tract infections are the most frequent cause of morbidity and the second leading cause of mortality Buzzell A Spinal Cord 2020 It is also the leading cause of healthcare use and consumption A Dinh MMI 2019 In addition multidrug-resistant bacteria MRB are frequently implicated accounting for up to 50 of cases Samal V BMC Infect Dis 2022 A Dinh Spnal cord 2016 due to high exposure to antibiotics and frequent and prolonged hospitalisations
The very frequent recurrence of urinary tract infections encourages exposure to antibiotics so prevention is of vital importance Prevention based on treatments other than antibiotics non-antibiotic prophylaxis is of the greatest interest not only to prevent UTIs but also to reduce exposure to antibiotics and the ecological pressure they exert However few strategies are available and very few have been well evaluated in high-risk populations
Bacterial lysates such as Escherichia Coli extract OM-89 an immunoactive prophylaxis are an original and innovative strategy that has been developed for the prevention of recurrent UTIs and could constitute a therapeutic option in particularly at-risk populations
In vivo studies have shown that OM-89
increases IgA levels in intestinal secretions and in the urine of mice Bosh AV Immunopharmacol Immunotoxicol 1988 Baier W Arzneim Forsch Drug Res 1997
stimulates the production of serum IgG and IgA recognising a number of bacteria isolated from patients with urinary tract infections and enterohaemorrhagic E coli infections Huber M Int J immunopharmacol 2000
stimulates the killing capacity of rabbit polymorphonuclear leukocytes against E coli and S aureus Nauck M Int J Exp Clin Chemother 1991
protects against acute infection with E coli or P aeruginosa
and inhibits inflammation associated with lipopolysaccharide-induced cystitis in mice Lee SJ World J Urol 2006
Clinically certain studies in patients with recurrent UTIs have shown a significant reduction in the number of urinary tract infections with OM-89 compared to placebo or an antibiotic Bauer Eur Urol 2005 Naber KG Int J Antimicrob Agents 2009 Wade DT Clin Rehabil 2020
However these promising results suffer from methodological limitations and need to be confirmed by a high-quality trial carried out on a sample appropriate to the research question and in a homogeneous patient population
Patients with spinal cord injuries are a population at high risk of recurrent UTIs and prevention is a major issue given the incidence of MRBs in this population It is therefore important in this high-risk population not only to rigorously evaluate the efficacy of OM-89 in reducing antibiotic consumption for UTIs but also to assess its impact on bacterial resistance and on the microbiota urinary and digestive These patients could therefore see significant benefits less frequent urinary tract infections and reduced antibiotic use In addition this population could serve as a model for other populations with or without neurological impairment suffering from recurrent UTIs
The very frequent recurrence of urinary tract infections encourages exposure to antibiotics so prevention is of vital importance Prevention based on treatments other than antibiotics non-antibiotic prophylaxis is of the greatest interest not only to prevent UTIs but also to reduce exposure to antibiotics and the ecological pressure they exert However few strategies are available and very few have been well evaluated in high-risk populations
Bacterial lysates such as Escherichia Coli extract OM-89 an immunoactive prophylaxis are an original and innovative strategy that has been developed for the prevention of recurrent UTIs and could constitute a therapeutic option in particularly at-risk populations
In vivo studies have shown that OM-89
increases IgA levels in intestinal secretions and in the urine of mice Bosh AV Immunopharmacol Immunotoxicol 1988 Baier W Arzneim Forsch Drug Res 1997
stimulates the production of serum IgG and IgA recognising a number of bacteria isolated from patients with urinary tract infections and enterohaemorrhagic E coli infections Huber M Int J immunopharmacol 2000
stimulates the killing capacity of rabbit polymorphonuclear leukocytes against E coli and S aureus Nauck M Int J Exp Clin Chemother 1991
protects against acute infection with E coli or P aeruginosa
and inhibits inflammation associated with lipopolysaccharide-induced cystitis in mice Lee SJ World J Urol 2006
Clinically certain studies in patients with recurrent UTIs have shown a significant reduction in the number of urinary tract infections with OM-89 compared to placebo or an antibiotic Bauer Eur Urol 2005 Naber KG Int J Antimicrob Agents 2009 Wade DT Clin Rehabil 2020
However these promising results suffer from methodological limitations and need to be confirmed by a high-quality trial carried out on a sample appropriate to the research question and in a homogeneous patient population
Patients with spinal cord injuries are a population at high risk of recurrent UTIs and prevention is a major issue given the incidence of MRBs in this population It is therefore important in this high-risk population not only to rigorously evaluate the efficacy of OM-89 in reducing antibiotic consumption for UTIs but also to assess its impact on bacterial resistance and on the microbiota urinary and digestive These patients could therefore see significant benefits less frequent urinary tract infections and reduced antibiotic use In addition this population could serve as a model for other populations with or without neurological impairment suffering from recurrent UTIs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None