Efficacy of Antibiotics in Children with Acute Sinusitis: Which Subgroups Benefit?

抗生素对急性鼻窦炎儿童的疗效：哪些亚组受益？

• 批准号: 8926122
• 负责人: Nader Shaikh
• 金额: $ 102.18万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-01 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8926122
• 关键词: 12 year old; Academy; Accounting; Acute; American; Amoxicillin; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Bacterial Infections; Child; Clavulanate; Clinical; Clinical Practice Guideline; Color; Controlled Clinical Trials; Data; Decision Making; Diagnosis; Diagnostic; Dose; Double-Blind Method; Electronics; Ensure; Fever; Goals; Guidelines; Haemophilus influenzae; Individual; Literature; Moraxella (Branhamella) catarrhalis; Nasopharynx; National Institute of Allergy and Infectious Disease; Nature; Nose; Outcome; Outcome Measure; Patients; Pediatrics; Placebo Control; Placebos; Population; Public Health; Randomized; Research; Respiratory System; Respiratory tract structure; Risk; Severities; Signs and Symptoms; Sinusitis; Streptococcus pneumoniae; Subgroup; Symptoms; Upper Respiratory Infections; Viral; Work; acute bacterial sinusitis; antimicrobial; base; clinical decision-making; diaries; evidence base; evidence based guidelines; experience; innovation; meetings; pathogen; placebo controlled study; public health relevance; respiratory; response

 DESCRIPTION (provided by applicant): Acute sinusitis is one of the most common diagnoses for which antimicrobials are prescribed for children in the US. Yet, available literature and our preliminary data suggest that only a subset of children diagnosed as having acute sinusitis based on current clinical criteria are likely to have bacterial disease. This finding, which is not entirely surprising, reflects the large overlap between symptoms and signs of an uncomplicated viral upper respiratory tract infection (URI) and acute bacterial sinusitis. Accordingly, in a population of children diagnosed as having acute sinusitis, response to antimicrobials is likely to be heterogeneous; those with true bacterial disease are likely to benefit substantially from antimicrobial therapy whereas those without bacterial disease would derive no benefit. The aim of this study is to identify subgroups of children who meet current diagnostic criteria for acute sinusitis, but in whom antimicrobial therapy provides no benefit. This objective will be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical trial in children 2 to 12 years of age with persistent or worsening presentations of acute sinusitis. Children will be randomized to receive amoxicillin-clavulanate or placebo. Based on preliminary data we have gathered, we hypothesize that the subgroup of children who harbor no respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis) in their nasopharynx, and the subgroup of children whose nasal discharge is grossly clear, are unlikely to have bacterial disease and therefore will not benefit from antimicrobial therapy. Innovations that will differentiate this study from previous studies include: 1) an experienced multidisciplinay research team working in a multicenter setting; 2) use of a well-validated measure of outcome; 3) use of electronic diaries to minimize the amount of missing data; and 4) a priori identification of subgroups likely to respond differently to antimicrobial therapy. Should the proposed hypotheses be borne out, clinicians would be provided a basis for restricting antimicrobial use to specific subgroups of children who are most likely to benefit from it. Reduction of unnecessary antimicrobial use constitutes an important contribution to both individual and public health and is in accord with our long-term goal and that of NIAID. Absent a study of this nature, it seems likely that many children with uncomplicated viral URI will continue to be treated inappropriately with antimicrobials. This trial will offer a departure from an "all-or-none" approach to decision-making regarding antimicrobials for acute sinusitis, and permit a more nuanced, evidence-based approach.

 描述（由适用提供）：急性鼻窦炎是为美国儿童开处方抗菌剂的最常见诊断之一。然而，可用的文献和我们的初步数据表明，只有基于当前临床标准的急性鼻窦炎诊断为急性鼻窦炎的儿童可能患有细菌疾病。这个发现，不是 总的来说，令人惊讶的是，反映了症状与单纯病毒上呼吸道感染（URI）和急性细菌性鼻窦炎之间的巨大重叠。彼此之间，在诊断为急性鼻窦炎的一群儿童中，对抗菌剂的反应很可能 是异质的；那些真正的细菌疾病的人可能会从抗菌治疗中受益匪浅，而那些没有细菌疾病的人不会获得任何益处。这项研究的目的是确定符合当前急性鼻窦炎诊断标准的儿童的亚组，但在其中抗菌治疗没有任何益处。这一目标将通过在儿童2到2的儿童中进行大型，随机，双盲，安慰剂控制的临床试验来实现 12岁，持续或担心急性鼻窦炎。儿童将被随机接受阿莫西林 - 克拉氏菌或安慰剂。根据我们收集的初步数据，我们假设没有伴随着没有呼吸道病原体的儿童（肺炎链球菌，嗜血杆菌的影响或莫拉氏菌Catarrhalis）在其鼻咽中的莫拉氏菌），以及他们的鼻腔分泌物的子组很明显，因此不适合细菌，因此有不错的症状。将这项研究与以前的研究区分开的创新包括：1）在多中心工作的经验丰富的多学科研究团队； 2）使用验证的结果测量； 3）使用电子日记来最大程度地减少丢失的数据量； 4）先验身份 对抗菌治疗的反应可能有所不同的亚组。如果提出的假设是诞生的，则将为临床医生提供限制抗菌用途的基础，以最有可能从中受益的儿童的特定子组。减少不必要的抗菌用途是对个人和公共卫生的重要贡献，是 根据我们的长期目标和NIAID的目标。缺乏对这种性质的研究，似乎很可能 许多具有简单病毒URI的儿童将继续用抗菌药物不适当地治疗。该审判将为决策提供与“全有或无人”的方法的背离 考虑用于急性鼻窦炎的抗菌素，并允许采用更细微的循证方法。