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COMPLETEDPHASE4

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)

NCT04322669•Almirall, S.A.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

3 - 14 years

Sex

ALL

Healthy Volunteers

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

Locations (16)

Investigator Site 01 Children's Hospital Captial Institute of Pediatrics

Beijing, China

Investigator Site 16

Changchun, China

Investigator Site 09

Changde, China

Investigator Site 12

Changsha, China

Investigator Site 07

Guangzhou, China

Investigator Site 10

Guilin, China

Investigator Site 14

Kunming, China

Investigator Site 03

Nanjing, China

Investigator Site 11

Sanya, China

Investigator Site 02

Shanghai, China

Key Dates

Start Date

August 4, 2021

Primary Completion Date

November 4, 2021

Completion Date

November 4, 2021

Last Updated

February 2, 2022

Enrollment

338

ACTUAL participants

Conditions

Recurrent Respiratory Tract Infections

Interventions

Pidotimod

DRUG

Placebo

DRUG

Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents

NCT06201494

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UNKNOWNNA

Evaluate the Effect of Nasal Spray in the Prevention of RTI in Children With Pre-school Wheezing

NCT05684848

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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