A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 35
- 主要终点
- Motavizumab Concentration in Nasal Wash Aspirates at Day 30
研究概览
简要总结
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
详细描述
The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children must meet all of the following criteria:
- •Previously healthy
- •Age less or equal to 12 months at the time of randomization
- •Gestational age more or equal to 36 weeks
- •Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
- •Documented positive RSV test within 48 hours prior to randomization
- •Randomization within 12 hours of the decision to hospitalize a child for RSV illness
- •Written informed consent obtained from the participant's parent(s)/legal guardian
排除标准
- •Children must have none of the following:
- •Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- •Any use of systemic or inhaled steroids within the past 30 days prior to randomization
- •Intubation for ventilatory support at randomization
- •Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
- •Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- •Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
- •Mechanical ventilation at any time prior to the onset of the current RSV infection
- •Congenital heart disease [children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
- •Previous reaction to IVIG, blood products, or other foreign proteins
- •Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
- •Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
- •Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
结局指标
主要结局
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
时间窗: Day 30
Motavizumab concentration in nasal wash aspirates is reported.
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0
时间窗: Day 0
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\<=12) months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
时间窗: Day 3
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
时间窗: Day 30
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
时间窗: Day 180
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
时间窗: Day 7
Motavizumab concentration in nasal wash aspirates is reported.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
时间窗: Day 1
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
时间窗: Day 2
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
时间窗: Day 4
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
时间窗: Day 6
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
时间窗: Day 90
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
时间窗: Day 1
Motavizumab concentration in nasal wash aspirates is reported.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
时间窗: Day 5
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
时间窗: Day 7
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
时间窗: Day 0
Motavizumab concentration in nasal wash aspirates is reported.
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
时间窗: Day 2
Motavizumab concentration in nasal wash aspirates is reported.
次要结局
- Oxygen Saturation Level During RSV Hospitalization(Days 0, 1, 2, 3, 7, and 30)
- Number of Participants With Supplemental Oxygen Use During RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels(Baseline (Day 0, pre-dose) through Day 180)
- Duration of Supplemental Oxygen Use During RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Number of Participants on Mechanical Ventilation During RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Duration of Mechanical Ventilation During RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs(From the start of study drug (Day 0) through Day 30)
- Duration of ICU Stay During RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Number of Participants With Detectable Anti-motavizumab Antibodies(Days 0, 180, and 360)
- Duration of RSV Hospitalization(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Respiratory Assessment Change Score (RACS) Derived From Baseline(Baseline (Day 0), Days 1, 2, 3, 7, and 30)
- Serum Concentration of Motavizumab(Days 1, 7, 90, 180, and 360)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From the start of study drug (Day 0) through Day 90)
- Heart Rate During RSV Hospitalization(Days 0, 1, 2, 3, 7, and 30)
- Respiratory Rate During RSV Hospitalization(Days 0, 1, 2, 3, 7, and 30)
- Number of Participants Admitted to the Intensive Care Unit (ICU)(From Randomization Day (Day 0) to Discharge Day (up to Day 30))
- Number of Participants With Medically-attended Wheezing Episodes(From randomization (Day 0) through Day 360 (approximately 12 months))
- Change From Baseline in Serum Cytokine Levels(Baseline (Day 0, pre-dose) through Day 360)