NCT04322669CompletedPhase 4
Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Almirall, S.A.
- Enrollment
- 338
- Locations
- 16
- Primary Endpoint
- Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 3 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pidotimod
Experimental
Intervention: Pidotimod (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
Time Frame: 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.
Secondary Outcomes
- 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))
Investigators
Study Sites (16)
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