EUCTR2022-000886-42-PL进行中（未招募）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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
入选标准
- •1. 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).
- •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.
- •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.
- •3. 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 426
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Anatomic alterations of the respiratory tract.
- •2. Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).
- •3. Any autoimmune disease.
- •4. HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
- •5. Known severe congenital heart disease.
- •6. Haematologic diseases.
- •7. Liver or kidney failure.
- •8. New-borns before 34 weeks of gestational age.
- •9. 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.
- •10. Any known neoplasia or malignancy.
- •11. 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.
- •12. Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
- •13. Any major surgery within the last 3 months prior to study enrolment.
- •14. Known allergy or previous intolerance to investigational medicinal products (IMP).
- •15. Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
- •16. No other household members have previously been randomised in this clinical study.
- •17. Subjects’ families expected to relocate out of study area within 24 months of the initiation of the study.
- •18. 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.
- •19. Parents or LAR who do not have access to internet connection.
- •20. Wheezing documented to be caused by gastroesophageal reflux.
研究者
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