PHASE III STUDY OF MEDI 493--RSV/PREMATURE INFANTS/INFANTS WITH BPD

MEDI 493--RSV/早产儿/患有 BPD 的婴儿的 III 期研究

• 批准号: 6116786
• 负责人: LEONARD E. WEISMAN
• 金额: $ 2.65万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6116786
• 关键词: bronchopulmonary dysplasia; chemoprevention; child (0-11); clinical research; drug screening /evaluation; health services research tag; hospital utilization; human subject; human therapy evaluation; immunotherapy; monoclonal antibody; premature infant human; respiratory infections; respiratory syncytial virus

The primary objective of this study is to compare the safety and efficacy of MEDI-493 (15mg/kg) to placebo when administered monthly by intramuscular injection for the reduction of the incidence of RSV hospitalization among infants born prematurely and infants with bronchopulmonary dysplasia (BPD). The secondary objectives of the study are to determine the effect of monthly MEDI-493 prophylaxis compared to placebo on RSV hospitalization parameters: total RSV hospital days, total RSV hospital days with increased supplemental oxygen requirement, total RSV hospital days with moderate or severe lower respiratory tract infection (LRI score >/= 3), frequency and total RSV-associated ICU days, frequency and total days of RSV-associated mechanical ventilation, incidence and total days of hospitalization for non-RSV respiratory disease and any respiratory disease and hospitalization for any cause, incidence of otitis media.

本研究的主要目的是比较安全性和 MEDI-493（15mg/kg）每月给药时相对于安慰剂的功效 肌肉注射以减少 RSV 的发生率 早产儿和患有以下疾病的婴儿住院 支气管肺发育不良（BPD）。 研究的次要目标 旨在确定每月 MEDI-493 预防的效果与 RSV 住院参数的安慰剂：RSV 住院总天数， 补充氧气需求增加的 RSV 住院总天数， 中度或重度下呼吸道感染 RSV 住院总天数 感染（LRI 评分 >/= 3）、频率和 RSV 相关 ICU 总数 RSV 相关机械通气的天数、频率和总天数， 非 RSV 呼吸道疾病的发生率和住院总天数 疾病和任何呼吸道疾病以及因任何原因住院， 中耳炎的发生率。