CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study (NCT01948856) | Clinical Trial Compass
CompletedPhase 3
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
Italy1,003 participantsStarted 2013-09
Plain-language summary
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.
Who can participate
Age range3 Years – 4 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2