Clinical trial NCT01948856: CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Upper-Respiratory Tract Infections
Keywords: Recurrent common cold
laryngitis
pharyngitis/tonsillitis
acute rhinitis
acute rhinosinusitis
acute otitis media
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 1003
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2
timeFrame: at each infectious episode over year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
city: L'aquila
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Varese
country: Italy
city: Kaunas
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
country: Lithuania
city: Lesznowola
country: Poland
city: Lublin
country: Poland
city: Ostroleka
country: Poland
city: Warszawa
country: Poland
city: Wegrow
country: Poland
city: Wolomin
country: Poland
city: Bacau
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Sibiu
country: Romania
city: Moscow
country: Russian Federation
city: St.Petersburg
country: Russian Federation
Study officials:
affiliation: Pierre Fabre Medicament
name: Karim KEDDAD, MD
role: STUDY_DIRECTOR
References: