A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Outpatient Treatment of Children With RSV Illness
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 33
- 主要终点
- Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
研究概览
简要总结
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.
详细描述
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Previously healthy
- •Age ≤12 months at the time of randomization
- •Weight ≤10 kg at the time of randomization
- •Gestational age ≥36 weeks
- •RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
- •Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50 breaths/minute in children 2-12 months)
- •Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
- •Randomization within 4 hours of being evaluated with a positive Binax® RSV test
- •Written informed consent obtained from the participant's parent(s) or legal guardian
排除标准
- •Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
- •Prior medically diagnosed RSV infection
- •Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
- •Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
- •Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- •Requirement for supplemental oxygen (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 arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
- •Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
- •Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
- •Prior use of palivizumab (Synagis®) within the past 2 months
- •Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- •Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
结局指标
主要结局
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0
时间窗: Day 0
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 2
时间窗: Day 2
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 90
时间窗: Day 90
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
RSV Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by RT-PCR at Day 30
时间窗: Day 30
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
次要结局
- Number of Participants Who Required Hospitalization, Intensive Care Unit (ICU) Stay, Supplemental Oxygen, and Mechanical Ventilation(Baseline (Day 0) to Day 90)
- Serum Concentration of Motavizumab(Days 2, 30, and 90)
- Serum Cytokine Levels(Days 0 (pre-dose), 30, and 90)
- Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization(From Randomiation (Day 0) Up to Day 30)
- Heart Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization(Baseline (Day 0) to Day 30)
- Number of LRI Infected Participants Who Required Hospitalization, ICU Stay, Supplemental Oxygen, Mechanical Ventilation, and Respiratory Medications(Baseline (Day 0) to Day 30)
- Motavizumab Concentration in Upper Respiratory Tract(Days 0 (pre-dose), 2, and 30)
- Numbers of Participants With Positive Anti-Motavizumab Antibodies(Days 0 (pre-dose) and 90)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From the administration of study drug (Day 0) through Day 90)
- Change From Baseline in Oxygen Saturation Level(Baseline (Day 0), Days 2, 7, and 30)
- Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization(Baseline (Day 0) to Day 30)
- Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization(Baseline (Day 0) to Day 30)
- Number of Participants Who Progresses From Upper Respiratory Tract Infection to Lower Respiratory Tract Infection (LRI)(Baseline (Day 0) to Day 30)
- Nasal Wash Cytokine Levels(Days 0 (pre-dose), 2, 30, and 90)
- Respiratory Assessment Change Score (RACS) Derived From Baseline(Baseline (Day 0); and Days 2, 7, and 30)
- Respiratory Rate of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization(Baseline (Day 0) to Day 30)
- Duration of Hospitalization, ICU Stay, Supplemental Oxygen Used, and Mechanical Ventilation Required(Baseline (Day 0) to Day 90)
- RACS in Participants With LRI(From Baseline (Day 0) to Days 2, 7, and 30)