NCT01486758已完成2 期
Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- IL-8 Concentrations
研究概览
简要总结
This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.
HYPOTHESES
In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:
- Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
- A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
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
- 1 Month 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 1-18 months.
- •Hospitalization for the first episode of RSV bronchiolitis:
- •Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
- •At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).
- •Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
- •Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
- •Willingness to provide informed consent by the child's parent or guardian
排除标准
- •Prematurity (gestational age < 36 weeks).
- •Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
- •Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
- •The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
- •History of previous (before the current episode) wheeze or previous treatment with albuterol.
- •Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
- •Treatment with any antibiotics in the past 2 weeks.
- •Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
- •Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
- •Participation in another clinical trial.
- •Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
- •Contraindication of use of azithromycin or any other macrolide antibiotics.
研究组 & 干预措施
Azithromycin
Active Comparator
Oral azithromycin
干预措施: Azithromycin (Drug)
Placebo
Placebo Comparator
Oral Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
IL-8 Concentrations
时间窗: Day 8
Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes
时间窗: 3-52 weeks following randomization
Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.
次要结局
- Concentrations of IL-8 in Nasal Lavage on Day 15(Day 15)
- Respiratory Symptoms Following RSV Bronchiolitis(3-52 weeks following randomization)
- Rates of Drug Related GI Side Effects.(One month from randomization)
- Likelihood to Develop 3 or More Wheezing Episodes(Week 3-52)
- Number of Children Who Were Prescribed Inhaled Corticosteroids(3-52 weeks following randomization)
- Proportion of Participants With a Physician Diagnosis of Asthma(Week 3-52)
研究者
Avraham Beigelman
Assistant Professor of Pediatrics
Washington University School of Medicine
研究点 (1)
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