Diagnosing Acute Bacterial Sinusitis in Children and Measuring Treatment Response

描述（由申请人提供）：鼻窦炎是美国第五大最常见的使用抗菌药物处方的诊断。然而，关于哪些体征、症状或细菌学检查结果最能确定儿童鼻窦炎的诊断，信息很少。由于没有明确的临床诊断标准，从业者很难区分儿童急性细菌性鼻窦炎与儿童单纯感冒。拟议的研究将检查临床和细菌学结果的诊断价值，单独和组合成一个临床预测工具，急性细菌性鼻窦炎。使用这些标准有可能减少这种经常发生的情况下不适当的抗菌药物使用。此外，在鼻窦炎研究中没有充分验证的方法来测量治疗反应。由于消除症状是抗菌治疗的一个重要目标，因此症状量表在逻辑上是临床试验中测量结果的理想方法。发展一个有效的症状量表，这是本建议的第二个目的，将允许研究人员比较急性鼻窦炎儿童的各种治疗策略的有效性。我们将招募260名年龄在2-12岁的疑似鼻窦炎儿童的前瞻性队列。在基线时，我们将收集有关体征和症状的详细信息，沿着鼻咽培养。所有儿童将接受鼻窦X线检查;有鼻窦炎X线证据的儿童将接受大剂量阿莫西林-克拉维酸治疗，并使用初步症状量表随访10天。我们将使用这些信息来确定哪些发现最能识别由阳性X线片定义的急性鼻窦炎儿童，并验证在未来试验中使用的症状量表。这项初步工作将为一项确定的多中心随机安慰剂对照研究奠定必要的基础，该研究评估了抗菌治疗儿童急性细菌性鼻窦炎的疗效。临床预测规则将告知研究的入选标准，症状量表将用作结局的主要结局指标。公共卫生相关性：使用通过这项研究确定的标准，从业者将能够更准确地区分需要抗生素的急性鼻窦炎儿童和不需要抗生素的感冒儿童。此外，我们还将开发一个症状量表，使研究人员能够比较不同治疗策略对急性细菌性鼻窦炎儿童的有效性。

DESCRIPTION (provided by applicant): Sinusitis is the 5th most common diagnosis warranting an antimicrobial prescription in the US. However, little information is available regarding which signs, symptoms, or bacteriologic findings best define a diagnosis of sinusitis in children. Without clear clinical diagnostic criteria, practitioners have had difficulty differentiating children with acute bacterial sinusitis from children with simple colds. The proposed research will examine the diagnostic value of clinical and bacteriologic findings, individually and combined into a clinical prediction tool, for acute bacterial sinusitis. Use of these criteria has the potential to reduce inappropriate antimicrobial use for this frequently occurring condition. Furthermore, there are no adequately validated methods of measuring treatment response in sinusitis studies. Since resolution of symptoms is an important goal of antimicrobial therapy, a symptom scale would logically be a desirable method of measuring outcome in clinical trials. Development of a valid symptom scale, which is the second aim of this proposal, will allow researchers to compare the effectiveness of various treatment strategies in children with acute sinusitis. We will enroll a prospective cohort of 260 children aged 2-12 years with suspected sinusitis. At baseline, we will collect detailed information regarding signs and symptoms, along with a culture from the nasopharynx. All children will undergo sinus radiography; those with radiographic evidence of sinusitis will be treated with high- dose amoxicillin-clavulanate and followed for 10 days using a preliminary symptom scale. We will use this information to determine which findings best identify children with acute sinusitis as defined by positive radiographs and to validate a symptom scale for use in future trials. This preliminary work will lay the necessary groundwork for a definitive multicenter randomized placebo- controlled study evaluating the efficacy of antimicrobial therapy in children with acute bacterial sinusitis. The clinical prediction rule will inform the inclusion criteria for the study and the symptom scale will be used as the primary outcome measure of outcome. PUBLIC HEALTH RELEVANCE: Using criteria identified through this study, practitioners will be able to more accurately separate children with acute sinusitis who need antibiotics from children with colds who do not. In addition, we will also develop a symptom scale which will allow researchers to compare the effectiveness of different treatment strategies for children with acute bacterial sinusitis.