EUCTR2016-000979-24-IT进行中（未招募）1 期
Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months. - ICASP (Infant Clinical Assessment Study on Paspat).
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
- 210
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
- •Patients with all the following criteria will be eligible for inclusion in the study protocol:
- •1. Male or female.
- •2. Aged 4 to 6 years achieved.
- •3. Patients with at least 6 URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
- •4. Children whose parent(s) or guardian(s) has (have) who given their written consent for participation in the study.
- •5. Possibility to have regular telephone contacts with patient’s parent(s).
- •6. Patients, and their parents, who are supposed will be cooperative with regard to compliance with study-related constraints.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 210
- •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
- •1. Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenoidectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tract due to intubation.
- •2. Anatomic abnormalities of oral, nasal or respiratory tracts.
- •3. Fever at the time of randomization.
- •4. Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
- •5. Acute broncho-pulmonary infection (bronchiolitis. pneumonia, tuberculosis) at the time of randomization.
- •6. Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
- •7. Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
- •8. Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
- •9. Known a-1 anti-trypsin deficiency from patient’s medical history/records.
- •10. Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
- •11. Acute intestinal infections.
- •12. Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
- •13. Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
- •14. Any on-going specific or non-specific immunotherapy with pharmacological effects on the immune system (including homeopathic or phytotherapy) whatever route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations.
- •15. Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
- •16. Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
- •17. Patient’s or family’s difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
研究者
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