Clinical trial NCT04322669: Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)
Official title: Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Respiratory Tract Infections
Keywords: Pidotimod
Recurrent Respiratory Tract Infections
Pediatrics Study
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 338
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)]
Secondary outcomes:
measure: Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Antibiotic Use Days During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Antibiotic Use Days During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Antibiotic Use Days During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Antipyretics Use Days During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Antipyretics Use Days During the Post-Treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Antipyretics Use Days During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Hospitalization Days During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Hospitalization Days During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Hospitalization Days During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Percentage of Participants with At Least One Hospitalization During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Wheezing Attack Days During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Wheezing Attack Days During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Wheezing Attack Days During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Asthma Days During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Asthma Days During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Asthma Days During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period
timeFrame: Baseline (Day 1) up to end of double-blind treatment (Day 60)
measure: Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period
timeFrame: From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET)
measure: Number of Participants with Adverse Events (AE) During the Overall Period
timeFrame: Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigator Site 01 Children's Hospital Captial Institute of Pediatrics
city: Changchun
country: China
facility: Investigator Site 16
city: Changde
country: China
facility: Investigator Site 09
city: Changsha
country: China
facility: Investigator Site 12
city: Guangzhou
country: China
facility: Investigator Site 07
city: Guilin
country: China
facility: Investigator Site 10
city: Kunming
country: China
facility: Investigator Site 14
city: Nanjing
country: China
facility: Investigator Site 03
city: Sanya
country: China
facility: Investigator Site 11
city: Shanghai
country: China
facility: Investigator Site 02
city: Shantou
country: China
facility: Investigator Site 06
city: Shaoyang
country: China
facility: Investigator Site 13
city: Tianjin
country: China
facility: Investigator Site 05
city: Xiamen
country: China
facility: Investigator Site 04
city: Yanji
country: China
facility: Investigator Site 08
city: Zhengzhou
country: China
facility: Investigator Site 15
Study officials:
affiliation: Almirall, S.A.
name: Study Director
role: STUDY_DIRECTOR
References: