Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)

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

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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• Participants who has previously completed or withdrawn from this study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