2/2: AZithromycin Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed at the Emergency Department (AZ-SWED)

2/2：阿奇霉素治疗在急诊科诊断出严重喘息发作的学龄前儿童 (AZ-SWED)

基本信息

批准号：
10263304
负责人：
Theron C Casper
金额：
$ 51.04万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-15 至 2025-11-15
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10263304
关键词：
6 year old Accident and Emergency department Acute Admission activity Age Ambulatory Care Facilities Anti-Bacterial Agents Antibiotics Antiinflammatory Effect Applied Research Asthma Azithromycin Bacteria Bacterial Infections Biological Biometry Cephalosporins Child Clinical Clinical Trials Clinical Trials Design Communication Data Collection Data Coordinating Center Data Set Diagnosis Double-Blind Method Emergency Care Emergency department visit Event Future Genetic Goals Guidelines Health Care Costs Hospitalization Human Resources Leadership Life Logistics Lower respiratory tract structure Macrolides Maintenance Manuals Microbe Microbiology Monitor Multi-Institutional Clinical Trial Nasopharynx Nursery Schools Outcome Penicillins Pharyngeal structure Placebo Control Placebos Play Population Preparation Preschool Child Prevalence Production Property Protocols documentation Randomized Recommendation Reporting Research Research Personnel Resistance Risk Risk Factors Role Sampling Severities Source Specimen Symptoms Technical Expertise Testing Toddler Training United States Universities Utah Virus Wheezing age group aged airway obstruction arm bacterial resistance clinical research site clinical trial analysis data management design disability efficacy testing emergency settings experience health care service utilization high risk hospitalization rates microbial microbial community operation pathogenic bacteria pediatric emergency psychologic respiratory response social symptomatic improvement treatment guidelines

项目摘要

Project Summary/Abstract Over 2.2 million children aged 2–5 years have wheezing episodes that are severe enough to require Emergency Department (ED) visits each year in the United States, and 15% of these children require hospitalization. There is new evidence suggesting that harmful bacteria growing in the throat may play an important role in determining which preschoolers will wheeze and then go on to develop asthma. Bacteria and viruses are equally associated with the risk of acute episodes of wheezing in preschoolers, and antibiotics may be a potential treatment. Two large, well-designed clinical trials performed in outpatient clinics recently showed a signiﬁcant reduction in severe symptoms when children were treated with the antibiotic Azithromycin (AZ) either before or after they started wheezing. Though these results are encouraging, we are not sure how this beneﬁt occurs since AZ has both anti-bacterial and anti-inﬂammatory effects. In addition, we do not know if AZ could be effective in more severe cases, like those requiring ED visits. The relatively underprivileged preschoolers who present to the ED for care of their severe wheezing episodes are usually sicker and with greater risk factors for bacterial infections. They are, therefore, the population that may get the greatest beneﬁt, if AZ is shown to be effective in this setting. We propose a trial in preschool age children coming to the ED with severe wheezing who will be treated with either AZ or placebo. We will also determine which bacteria are growing in the children's pharynx. This will answer the question “Does Azithromycin make children with severe wheezing better sooner and, if so, is that beneﬁt seen in all the children treated or only in those with potentially harmful bacteria in their throats?” There is concern that excessive use of antibiotics may cause bacterial resistance to their effects. We will thus determine if genetic factors or the populations of microbes present in the pharynx can identify children that are more likely to respond to AZ. This will allow us to target the use of AZ to these children in the future. By testing treatment of high risk children with severe wheezing in the ED with AZ and determining which bacteria are growing in their throats, our study may identify a new way to treat these severe, frightening, and difﬁcult to treat illnesses.

项目摘要/摘要超过220万年龄在2-5岁的儿童的喘息情节很严重，需要紧急部门（ED）每年在美国访问，其中15％的孩子需要住院。那里有新证据表明，喉咙中生长的有害细菌可能在确定中起重要作用学龄前儿童将继续前进，然后继续发展哮喘。细菌和病毒同样相关在学龄前儿童中有急性发作的风险，抗生素可能是一种潜在的治疗方法。二在门诊诊所进行的大型，精心设计的临床试验最近显示出严重的重大减少儿童在开始之前或之后用抗生素阿奇霉素（AZ）治疗儿童时的症状乘坐。尽管这些结果令人鼓舞，但我们不确定这种好处是如何发生的抗菌和抗炎性效应。此外，我们不知道AZ是否可以在更严重的情况下有效案件，例如需要埃及访问的案例。相对贫困的学龄前儿童，向ED出席护理它们的严重喘息发作通常病得多，细菌感染的危险因素更大。他们因此，如果AZ在这种情况下有效，则可能获得最大的好处的人群。我们提议在学龄前儿童的审判中，以严重的旋转为急诊室 AZ或安慰剂。我们还将确定儿童咽部中哪些细菌正在生长。这将回答问题：“阿奇霉素是否会使患有严重旋转的儿童早日更好，如果是这样，那是好处在所有接受治疗的孩子中，或者仅在喉咙中有潜在有害细菌的患者中？过量使用抗生素可能会对其作用引起细菌抗性。因此，我们将确定是否遗传咽中存在的微生物的因素或人群可以识别更有可能做出反应的儿童到AZ。这将使我们将来针对这些孩子使用AZ。通过测试高风险的治疗与AZ一起在ED中有严重旋转的儿童，并确定哪些细菌在喉咙中生长，我们研究可能会确定一种治疗这些严重，令人恐惧和困难治疗疾病的新方法。