EUCTR2008-000487-17-IT进行中（未招募）不适用
Clinical trial of the efficacy and tolerability of an immunostimulant drug, composed by ribosomal fractions, in socialized paediatric patients in order to prevent recurrent respiratory infections. A randomized, double -blind vs. placebo, multicentric study. - ND
PIERRE FABRE PHARMA0 个研究点开始时间: 2008年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Children of both sex between 2-5 years old, already socialized or to be socialized (nursery school or preschool) in the following three months after been included in the study.
- •2.Absence of malformations and/or clinically significant pathologies in progress.
- •3.Parents (o legal guardians) and/or children who are able to understand and follow what the study protocol demands
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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.Any RRI episode in the 7 days prior randomization
- •2.Infective and non infective acute episodes in progress during randomization in any body system which require hospital recovery and/or intensive therapy
- •3.Gastroesophageal reflux
- •4.Cistic Fibrosis, deficit of α 1-antitrypsin, ciliary dyskinesia
- •5.Severe and chronic pathologies in any body system.
- •6.Corporal mass less than 3rd percentile of the respective age.
- •7.Autoimmune disease carrier.
- •8.Any product belonging to the groups ATC J06 (immune serum and immunoglobulins) or J07AX (immunostimulants) two weeks before the recruitment.
- •9.Treated two weeks prior the recruitment or presumed necessity of treatment for the entire period of study (including the follow up period) with:
- •Immunostimulants belonging to the group J07AX ATC;
- •Antineoplastic drugs belonging to the group L01 ATC;
- •Drugs belonging to the groups L03 and L04 ATC like cytokines, interleukins, interferon, immunosoppressors;
- •systemic corticosteroids;
- •pharmaceutical products or food supplies who?s ingredients contain zinc;
- •any ethical, over the counter, herboristic (eg. echinacea) or homeopathic product that have immunonostimulant properties as one of their indications.
- •10.History of allergy or intolerance to the studied products and/or one of the excipients
- •11.Parents (or legal guardians) and/or patients that can?t understand the information given in order to obtain informed consent or that refuse to give a written informed consent due to linguistic or psychological factors.
- •12.Parents (or legal guardians) that have lost the guardianship.
- •13.Parents (or legal guardians) and/or patients that can?t be contacted during the study.
- •14.Participation to other clinical studies within a month prior or during the study.
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