Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
研究概览
简要总结
The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.
详细描述
Azithromycin (AZI), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 For pediatric critical asthma (CA), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (PICU) hospitalization, the investigator's prior research has revealed 1 in 10 will receive AZI.2 Yet, the application of AZI in this setting is poorly studied nor is clear if, and to what degree AZI alters the immune response in conjunction with systemic corticosteroids traditionally applied in CA.
In this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with CA with and without exposure to AZI. The investigators hypothesize children receiving AZI will have lower periostin levels. As a secondary analysis, the investigators will describe the rates of adverse events related to AZI (previously not done) and explore differences in clinical and physiologic CA efficacy markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-17 years
- •Admission to the PICU
- •Primary diagnosis of critical asthma
- •Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy
- •Prescription for intravenous systemic corticosteroids
排除标准
- •Critical Congenital Heart Disease Unrepaired
- •Tracheostomy Dependence at Admission
- •Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication
- •Past Medical History of Prolonged QT Syndrome or Arrhythmias
- •Concomitant respiratory pathology including Acute Chest Syndrome, Interstitial Lung Disease, Cystic Fibrosis, and pulmonary hypertension
研究组 & 干预措施
Standard Care
Participants will receive standard care without Azithromycin.
Azithromycin Intervention
Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint
时间窗: 24 hours, 48 hours, and 72-hours following enrollment
ng/dL
Drug-related adverse event rate (Primary Safety Endpoint)
时间窗: During hospitalization, approximately 3 days
cumulative incidence rate
次要结局
- Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)(During hospitalization, approximately 3 days)
- Length of Stay (Secondary Clinical Efficacy Endpoint)(During hospitalization, approximately 3 days)
- Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)(Enrollment, Day 1, Day 2, Day 3, at ICU Discharge)
- Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)(During hospitalization, approximately 3 days)