CTIS2024-511581-37-00招募中1 期
A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness - BV-2020/08
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- OM Pharma SA
- 入组人数
- 426
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Children of either gender aged between 6 months and 5 years at Baseline/Randomisation (Visit 2), inclusive. As requested by the Central Ethics Committee, in Italy children can be enrolled if they are between 1 year and 5 years of age at baseline/Randomisation (Visit 2)., For children =1 year of age, =4 RTIs (as reported by parents or LAR of subject), including =2 episodes of wLRIs (including =1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR For children <1 year of age, =2 RTIs (as reported by parents or LAR of subject), including =1 episode of wLRIs (including =1 triggering hospitalisation or medical visit) within 6 months prior to enrolment., Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
排除标准
- •Anatomic alterations of the respiratory tract., Any known neoplasia or malignancy., Treatment with the following medications: a. Injection or oral steroids administration within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment., Previous use within last 6 months of enrolment or ongoing use of bacterial lysates., Any major surgery within the last 3 months prior to study enrolment., Known allergy or previous intolerance to investigational medicinal products (IMP)., Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study., No other household members have previously been randomised in this clinical study., Subjects' families expected to relocate out of study area within 24 months of the initiation of the study., Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within <30 days prior to screening., Parents or LAR who do not have access to internet connection., Other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis)., Wheezing documented to be caused by gastroesophageal reflux., Any autoimmune disease., HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency)., Known severe congenital heart disease., Haematologic diseases., Liver or kidney failure., New-borns before 34 weeks of gestational age., Malnutrition as per World Health Organization (WHO) definition, meaning children having a weight lower than the 5th percentile and higher than the 85th percentile for their age range according to WHO weight for age charts from birth to 5 years. Children of 6 months of age at enrolment will be excluded from the study if they have a weight lower than 6 kg and 6.6 kg, for girls and boys respectively.
研究者
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