Recurrent Upper-Respiratory Tract Infections (RURTI) MedDRA version: 17.0 Level: PT Classification code 10046306 Term: Upper respiratory tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: IMMUCYTAL granules for oral solution
Product Code: J022XST
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: RIBOSOMAL FRACTIONS
Current Sponsor code: J022XST
Concentrat
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria in Year 1 Patients with all the following criteria will be eligible for inclusion in Year 1: Demographic Characteristics and Other Baseline Characteristics: - Children, male or female - Aged 3 to 4 years Diagnostic Criteria : - 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). Ethical / legal considerations: - Children whose parent(s) or guardian(s) has (have) given his/her (their) written consent for the child's participation in the study, according to national regulations. - Children whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints. - Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation) Inclusion criteria in Year 2 Patients with all the following criteria will be eligible for randomisation in Year 2: Demographic Characteristics and Other Baseline Characteristics: - Children, male or female - Aged 4 to 5 years Diagnostic Criteria: - Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study. Ethical / legal considerations: - Children whose parent(s) or guardian(s) has (have) confirmed his/her (their) written consent for the child's participation in the study, according to national regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 1000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other diseases: - Foreign body, nasal tumor, anatomic abnormality such as palatine groove - Previous history of tube insertions in the respiratory tract. - Previous surgery in the respiratory tract. - Chronic suppurative otitis media. - Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy. - Acute broncho-pulmonary infection (bronchiolitis. pneumonia, tuberculosis). - Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral/inhalers) or bronchiectasis regularly treated with corticosteroids. - Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome). - Medically treated gastro-oesophageal reflux. - Known HIV infection or any type of iatrogenic or congenital immune deficiency (including IgA deficiency). - Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis). - Congenital heart disease and haematologic diseases. - Cancer. - Known a-1 anti-trypsin deficiency from patient’s medical history/records. - Under-nourished children and children with backwardness of growth (<80% of the average weight for the age). Relating to treatments: - Medical history of hypersensitivity to J022X ST or any drug excipients - Any on-going specific or non-specific immunotherapy whatever the route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations. - Chronic use of corticosteroids: intravenous, intramuscular, oral, inhaled, nasal or ocular solution. - Chronic use of bronchodilators - Treatment with antileukotriens - Homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity. Others: - Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…) - Is participating or has participated in another clinical trial within the last month, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial - Concomitant participation of another sibling in the same family. - Uncooperative parents (or guardians) expected difficulties in obtaining signature of one (both) parent(s) (or guardians), in follow-up or compliance. - One (both) parent(s) (or guardians) or patient who, in the judgment of the investigator, is/are not likely to be compliant during the study. - One (both) parent(s) (or guardians) who, in the judgment of the investigator, is/are mentally unable to understand the nature, objectives and possible consequences of the trial. - One (both) parent(s) (or guardians) who has (have) forfeited his/her (their) freedom by administrative or legal award, or that is/are under guardianship. - Parent(s) (or guardians) who cannot be contacted in case of emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of J022X ST in preventing RURTI in young children at risk.;Secondary Objective: To evaluate the consequences of URTI on absenteeism (children and parents), hospitalisation, use of other treatments for children To evaluate the ENT and broncho-pulmonary complications of URTI To document the safety of J022X ST;Primary end point(s): Number of URTI episodes medically assessed over year 2;Timepoint(s) of evaluation of this end point: For primary statistical analysis criterion evaluated over 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Severe URTI: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events - Hospitalisation caused by URTI: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Broncho-pulmonary infections: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Otitis media: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Clinical signs of asthma: number of occurrences, mean number of days per child, percentage of children with at least one event, percentage of events. - Antibiotics, NSAIDs and/or corticoids for URTI: number of occurrences, mean number of days per child, percentage of children with at least one event. - Absenteeism from daycare institutions/nursery school for the child: number of occurrences, mean number of days per child, percentage of children with at least one event. - Absenteeism from work for parent(s): number of occurrences, mean number of days per child, percentage of children whose parents have at least one event. - Time to first URTI episode - Quality of life (PAR-ENT QoL) - Safety of J022X ST: number and type of adverse events;Timepoint(s) of evaluation of this end point: During year 1: evaluation criteria collected at D1, extra-visits at each URTI episode, month 12 except for Quality of life (PAR-ENT QoL) that is collected at only month 12 During year 2:evaluation criteria collected at D1, extra-visits at each URTI episode, Month 3, Month 6, Month 9 and month 12 except for Quality of life (PAR-ENT QoL) that is collected at D1, Month 3, Month 6, Month 9 and month 12 | — |
Countries
Italy, Lithuania, Poland, Russian Federation
Contacts
Public ContactClinical study manager (monitor)
PIERRE FABRE MEDICAMENT
Outcome results
None listed