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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：
9891812
负责人：
Theron C Casper
金额：
$ 90.67万
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 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9891812
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 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 implementation trial 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.

项目总结/摘要超过220万名2 - 5岁的儿童有严重到需要紧急治疗的喘息发作在美国，每年都有艾德（ED）就诊，其中15%的儿童需要住院治疗。那里新的证据表明，生长在喉咙里的有害细菌可能在决定学龄前儿童会气喘并发展成哮喘。细菌和病毒同样与与学龄前儿童喘息急性发作的风险，抗生素可能是一种潜在的治疗方法。两最近在门诊进行的大型、精心设计的临床试验显示，当儿童在开始使用抗生素阿奇霉素（AZ）之前或之后接受治疗时，气喘虽然这些结果令人鼓舞，但我们不确定这种好处是如何产生的，因为AZ既有抗菌和抗炎作用。此外，我们不知道AZ是否能有效治疗更严重的疾病，比如需要去艾德就诊的病例。向艾德寻求照顾的相对贫困的学龄前儿童他们的严重喘息发作通常病情更重，细菌感染的风险因素更大。他们因此，如果AZ在这种情况下被证明是有效的，那么这些人可能会获得最大的好处。我们我建议在来艾德的学龄前儿童中进行一项试验，这些儿童患有严重的喘息，他们将接受以下两种治疗： AZ或安慰剂。我们还将确定哪些细菌在儿童的咽部生长。这将回答问题：阿奇霉素是否能使严重喘息的儿童更快好转，如果是，是否能看到这种益处在所有接受治疗的儿童中，还是仅在那些喉咙里有潜在有害细菌的儿童中？"有人担心过度使用抗生素可能会导致细菌对其作用产生耐药性。因此我们将确定是否遗传存在于咽部的微生物的因素或群体可以识别更有可能响应的儿童到AZ。这将使我们能够在未来针对这些儿童使用AZ。通过测试治疗高风险在患有AZ的艾德急诊室中患有严重喘息的儿童，并确定哪些细菌在他们的喉咙中生长，我们这项研究可能会找到一种新的方法来治疗这些严重，可怕和难以治疗的疾病。