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

Recurrent Upper-Respiratory Tract Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948856
• Other study ID #: J0022X ST 3 02
• Secondary ID: 2013-001760-31
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2013
• Last updated: February 2, 2017
• Start date: September 2013
• Est. completion date: December 13, 2016

Study information

• Verified date: February 2017
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: December 13, 2016
• Est. primary completion date: October 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Recurrent Upper-Respiratory Tract Infections
• Respiratory Tract Infections

Intervention

Drug:
• J022X ST
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
• Placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Italy,  Lithuania,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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