OM85 in the prevention of respiratory infections in elderly patients at risk
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo.
研究概览
简要总结
To evaluate whether and to what extent OM85 compared to placebo is able to reduce Respiratory Tract Infections (RTIs) in a period of 12 months in a population of elderly subjects, residing in Healthcare Residence, and with a history of at least two respiratory tract infections in the 12 months before enrollment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Total duration of treatment
- 盲法
- Double (Investigator, Analyst, Carer, Subject, Monitor)
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age 75 years or older.
- •At least 2 RTIs in the year preceding enrollment.
- •Patients must have resided in the Healthcare Residence for at least 6 months and have an expected stay in the Healthcare Residence of at least 6 months according to the physician judgement
- •Signed informed consent. For participants unable to provide informed consent due to cognitive deficits, consent will be provided by a legally recognized representative or a patient trustee (pursuant to article 4 of law 22 December 2017, n. 219).
- •Have a life expectancy of at least one year according to the physician judgement.
排除标准
- •Patients with known allergy or previous intolerance to the study drug
- •Patients with active neoplasm and prognosis of less than one year
- •Patients with previous organ transplant
- •Patients treated with the following drugs: immunosuppressive or immunostimulatory therapy in the 3 months before the start of the study
- •Patients who have taken bacterial lysates in the 6 months prior to enrollment or who are currently using them
- •Patients treated regularly with oral corticosteroids
- •Patients who are unable to follow instructions and unreliable patients (including patients with alcoholism or patients unwilling to give informed consent or comply with protocol requirements).
- •Patients with any other clinical condition that, in the opinion of the investigator, would not allow the protocol to be completed and the study drugs to be administered safely.
结局指标
主要结局
The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo.
The measured variable will be the number of respiratory tract infections (RTIs) in the two groups during the treatment period (6 months) and until the end of the observation period (further 6 months) after the start of administration of OM 85 or placebo.
次要结局
- rate of hospital admissions and emergency room visits in the 12 months following the start of the intervention in the OM 85 or placebo group
- consumption of antibiotics in the 12 months following the start of the intervention
- evaluation of the incidence of adverse events of OM-85 in elderly patients at risk by reviewing medical records
研究者
Prof. Raffaele Antonelli Incalzi
Scientific
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon