A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation.

Abbott Laboratories LLC0 个研究点目标入组 100 人开始时间: 2015年2月3日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•1. Infants at high risk of severe RSV infection fulfilling at least one of the following:
•a. Infants born = 35 weeks gestational age AND = 6 months of age at
•enrollment;
•b. Infants = 24 months of age at enrollment AND with a diagnosis of BPD
•(defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) any time within 6 months prior to enrollment;
•c. Infants = 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, not operated or partially corrected. Infants with acyanotic cardiac lesions had to have pulmonary hypertension (= 40 mm Hg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage CHD.
•Infants with the following conditions were not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosus, infants with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone.
•2. Informed Consent Form signed by parent(s).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•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

•Subjects meeting any of the following criteria are not eligible for the study:
•1.Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days).
•2.Mechanical ventilation (including continuous positive airway pressure [CPAP]) at the time of enrollment.
•3.Life expectancy less than 6 months.
•4.Active respiratory illness, or other acute infection.
•5.Known renal impairment, as determined by the investigator.
•6.Known hepatic impairment, as determined by the investigator.
•7.History of seizures (except neonatal seizures).
•8.Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly).
•9.Known immunodeficiency, as determined by the investigator.
•10.Allergy to immunoglobulin products.
•11.Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin).
•12.Participation in another clinical trial within 30 days prior to enrollment.
•13.Previous enrollment in this trial.
•14.For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

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