EUCTR2013-001760-31-LT进行中（未招募）1 期
Clinical efficacy and safety of J022X ST in the prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) in children with a high risk of recurrence - CLEARI (CLinical Efficacy Assessment on RurtI) study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •The patients who are included have to be aged from 4 to 5 years between September to October of the randomisation year.
- •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
排除标准
- •Other diseases:
- •- Foreign body, nasal tumor, anatomic abnormality such as palatine groove
- •- Previous major surgery in the respiratory tract (not included tonsillectomy or adenectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tract due to tube insertion.
- •- 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) ) (i.e. persistent forms in accordance with GINA classification) or bronchiectasis regularly treated with corticosteroids.
- •- Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
- •- Medically ongoing treatment for 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 (unresolved with ongoing medical symptoms) and severe haematologic diseases (except mild anemia without need for treatment).
- •- 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 with pharmacological effects on the immune system (including homeopathic or phytotherapy) 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 (over 2 consecutive weeks for maintenance therapy): intravenous, intramuscular, oral, inhaled, nasal, auricular or ocular solution.
- •- Chronic use of bronchodilators (over 2 consecutive weeks for maintenance therapy)
- •- Treatment with antileukotriens
- •- Any homeopathic or phytotherapy treatment (except for acute flare up but not over 2 consecutive weeks)
- •- 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.
研究者
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