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临床试验/NCT04322669
NCT04322669已完成4 期

Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)

Almirall, S.A.16 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2021年8月4日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
338
试验地点
16
主要终点
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
3 Years 至 14 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed
  • •Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:
  • •at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion
  • •OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months
  • •Participants compliant with the pidotimod Chinese approved label (package insert) requirements

排除标准

  • •Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
  • •Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
  • •Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
  • •Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
  • •Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
  • •Participants who has previously completed or withdrawn from this study
  • •Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion
  • •Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study
  • •Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
  • •Parents/Caregivers without cell phone, tablet or computer availability

研究组 & 干预措施

Pidotimod

Experimental

干预措施: Pidotimod (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period

时间窗: Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]

The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups.

次要结局

  • Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Antipyretics Use Days During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Percentage of Participants with At Least One Hospitalization During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Wheezing Attack Days During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Wheezing Attack Days During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Antibiotic Use Days During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Antibiotic Use Days During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Antipyretics Use Days During the Post-Treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Antipyretics Use Days During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Hospitalization Days During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Hospitalization Days During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Hospitalization Days During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Antibiotic Use Days During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Wheezing Attack Days During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Asthma Days During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Asthma Days During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Asthma Days During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period(Baseline (Day 1) up to end of double-blind treatment (Day 60))
  • Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period(From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET))
  • Number of Participants with Adverse Events (AE) During the Overall Period(Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (16)

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