Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655272
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
OM 85 to Prevent Respiratory Infections in Older At Risk Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
OM85OLDER
Brief Summary:
People living in NH are at higher risk of respiratory infections compared to their counterpart living in the community Products obtained from dead bacteria bacterial lysate can be used to boost immune system and may reduce the risk of respiratory infections Very little information is available on the effect of these substances in older people This study will evaluate the efficacy of a bacterial lysate in reducing the incidence of lower respiratory tract infections in older people living in nursing homes The study will include a treatment arm in which participants will received the lysate and a control arm in which participants will received a matching placebo ie a pill that has the same appearance of the lysate but does not contain the lysate itself
Detailed Description:
OM 85 lyophilized bacterial lysate proved effective in increasing the immune response against bacteria in animal models Furthermore its use was shown to be associated with lower incidence of RTIs in children and at risk adults However there is a paucity of information about OM 85 efficacy in the elderly ie in a population which due to immunosenescence and multimorbidity might have a distinctive response to this immunostimulating strategy Indeed the only study properly designed for a geriatric population is a randomized controlled trial on 290 people over-65 with chronic bronchitis and frequent exacerbations here a significant decrease in the incidence of acute bronchitis was observed in the OM 85 group over 6 months Orcel B et al Eur Respir J 1994 7 446-452 However this population seems poorly representative of the average older population at risk of RTI Indeed chronic diseases like congestive heart failure and chronic renal failure qualified as exclusion criteria Furthermore a history of at least 4 episodes of acute bronchitis treated with antibiotics in the 6-month reference period of the previous year were requested for the enrollment Thus the study population is unlikely to reflect the profile of risk of the elderly and frail population which is characterized by a high prevalence of chronic diseases but not by such a high incidence of respiratory infections Indeed even in severe COPD the frequency of exacerbations rarely exceeds 2 yearly and is rapidly declining Andreas et al Respiratory Research 2019 20186 Geriatric patients are variably represented in other studies which proved the efficacy of OM 85 in adult populations with COPD or chronic bronchitis Twelve studies met the quality criteria to be eligible for a recently published meta-analysis Huang Y Pei Y Qian Y Yao Z Chen C Du J Shi M and Zhou T 2022 A meta-analysis on the efficacy and safety of bacterial lysates in chronic obstructive pulmonary disease Front Med 9877124 doi 103389fmed2022877124 However elderly patients and especially those over 75 the most vulnerable to respiratory infections were a minority of probands Furthermore the selection criteria pointed at COPD as the main disease in the vast majority of the studies IMP has never been tested in an older population with a heavy burden of multimorbility and frailty and a high risk of RTI I e in the population most likely to benefit from it Accordingly this trial is expected to clarify what previous studies could not because they were not designed to study this kind of population and only sparse and partial information could be derived by picking selected patients from the study populations Furthermore all our patients will receive the recommended vaccines and this will allow test IMP in a framework free from confounding by heterogeneity in vaccine policy
Primary objective
To evaluate whether and to which extent OM85 compared with placebo is able to reduce respiratory tract infections RTIs over a 12-month period in a population of subjects aged 75 years and older residing in nursing homes and with a history of at least two RTIs in the 12 months prior to enrollment
Secondary objectives
To verify whether the rate of hospital admissions and emergency department visits due to RTI decreases from the previous year differently in the OM 85 group compared with placebo
Evaluate the number of antibiotic prescriptions between the two groups OM 85 and placebo during the 12-month study period
Describe the demographic clinical and functional characteristics of patients with higher RTI numbers
Evaluate the incidence of treatment-emergent adverse events TEAEs
Primary objective
To evaluate whether and to which extent OM85 compared with placebo is able to reduce respiratory tract infections RTIs over a 12-month period in a population of subjects aged 75 years and older residing in nursing homes and with a history of at least two RTIs in the 12 months prior to enrollment
Secondary objectives
To verify whether the rate of hospital admissions and emergency department visits due to RTI decreases from the previous year differently in the OM 85 group compared with placebo
Evaluate the number of antibiotic prescriptions between the two groups OM 85 and placebo during the 12-month study period
Describe the demographic clinical and functional characteristics of patients with higher RTI numbers
Evaluate the incidence of treatment-emergent adverse events TEAEs
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