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.

项目概要/摘要超过 220 万 2 至 5 岁儿童出现严重喘息，需要紧急救治在美国，每年急诊科就诊，其中 15% 的儿童需要住院治疗。新证据表明，喉咙中生长的有害细菌可能在确定学龄前儿童会出现喘息，然后发展为哮喘，这与细菌和病毒同样相关。学龄前儿童有急性喘息发作的风险，抗生素可能是一种潜在的治疗方法。最近在门诊进行的大型、精心设计的临床试验表明，重症病例显着减少儿童在开始之前或之后接受抗生素阿奇霉素 (AZ) 治疗时出现的症状尽管这些结果令人鼓舞，但我们不确定这种益处是如何实现的，因为 AZ 两者兼而有之。此外，我们不知道AZ是否对更严重的情况有效。情况，例如需要急诊科就诊的相对贫困的学龄前儿童。他们的严重喘息发作通常病情较重，细菌感染的危险因素也更大。因此，如果 AZ 在这种情况下被证明是有效的，那么这些人群可能会获得最大的利益。建议对前往急诊室的患有严重喘息的学龄前儿童进行试验，他们将接受以下任一治疗我们还将确定哪些细菌在儿童的咽部生长，这将回答这个问题。问题“阿奇霉素是否能让患有严重喘息的儿童更快好转？如果是这样，这种好处是否可见？” 在所有接受治疗的儿童中，还是仅在那些喉咙中存在潜在有害细菌的儿童中？” 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。咽部存在的因素或微生物群可以识别更有可能做出反应的儿童这将使我们能够在未来通过测试高风险的治疗来针对这些儿童使用 AZ。急诊科患有严重喘息的儿童并患有 AZ 并确定哪些细菌在他们的喉咙中生长，我们的研究可能会找到一种新方法来治疗这些严重、可怕且难以治疗的疾病。