CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.

Conditions
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Recurrent Upper-Respiratory Tract Infections

Intervention / Treatment
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* Drug: J022X ST
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients with all the following criteria will be eligible for inclusion in Year 1: Children, male or female Aged 3 to 4 years Children known for recurrent URTIs in the past year (based on medical recording or reported history) Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive). Patients with all the following criteria will be eligible for randomisation in Year 2: Children, male or female Aged 4 to 5 years Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study. Key Exclusion Criteria: Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis…) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: J022X ST<br> | Drug: J022X ST<br>* Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach First month: 4 consecutive days per week during 3 consecutive weeks 5 next months: 4 consecutive days per month at monthly intervals<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach First month: 4 consecutive days per week during 3 consecutive weeks 5 next months: 4 consecutive days per month at monthly intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2 | Each URTI episodes will be medically assessed by the investigator by a thorough medical examination. | at each infectious episode over year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent common cold, laryngitis, pharyngitis/tonsillitis, acute rhinitis, acute rhinosinusitis, acute otitis media