Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 15
- 主要终点
- Length of Hospitalization
研究概览
简要总结
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.
详细描述
The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 10 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
- •Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow
- •Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
- •Onset of RSV-related symptoms must be less than 5 days
- •Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.
排除标准
- •AZM use within 7 days of ICU admission;
- •Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
- •Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
- •Intensive respiratory support greater than 48 hours prior to ICU admission;
- •Chronic ventilation or supplemental oxygen need at home;
- •Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
- •History of pyloric stenosis;
- •AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).
研究组 & 干预措施
Control Group
干预措施: Control Group (Other)
AZM 20mg/kg Treatment Group
干预措施: AZM Group (Drug)
结局指标
主要结局
Length of Hospitalization
时间窗: At discharge (Approximately 2 weeks)
Duration of hospitalization in days for enrolled subjects
次要结局
- Duration of oxygenation(At discharge (Approximately 1 week))
- Length of ICU stay(At ICU discharge (Approximately 1 week))
研究者
Michele Kong, MD
PI
University of Alabama at Birmingham