Reduction of Uneccessary Antibiotics in Adults by the Use of Viral Diagnostics

通过使用病毒诊断减少成人不必要的抗生素

• 批准号: 7915044
• 负责人: Ann R Falsey
• 金额: $ 6.89万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7915044
• 关键词: Accounting; Acute; Admission activity; Adult; Adverse event; Affect; Antibiotics; Antimicrobial Resistance; Bacteria; Bacterial Infections; Biological Markers; Clinical; Data; Diagnosis; Diagnostic; Enrollment; Frequencies; Grant; Health Care Costs; Hospitalization; Hospitals; Incidence; Infection; Intervention; Intervention Studies; Laboratories; Length of Stay; Molecular; Morbidity - disease rate; Outcome; Patient Care; Patients; Phase; Physicians; Public Health; Randomized; Recommendation; Recruitment Activity; Respiratory System; Respiratory Tract Infections; Respiratory tract structure; Risk; Secondary to; Serum; Techniques; Upper arm; Viral; Viral Respiratory Tract Infection; Virulent; Virus; Virus Diseases; base; clinical practice; cost; group intervention; improved; meetings; microbial; mortality; pathogen; patient population; procalcitonin; public health relevance; respiratory; respiratory virus; routine care; standard care

DESCRIPTION (provided by applicant): Acute respiratory tract infections are one of the most common reasons for hospital admission in adults. In clinical practice antibiotics are nearly universally administered because a specific microbial diagnosis is often not made. Recent evidence using sensitive molecular techniques indicate that a significant proportion of these illnesses are due to viruses. Although viral infection may predispose to secondary bacterial infections, the actual incidence has been poorly studied and is likely overestimated. If antibiotic use was targeted to only those patients with true bacterial co-infection and not to those with viral infection alone, overall patient care would be improved by reducing antibiotic related complications, spread of antimicrobial resistant bacteria, and overall costs. In this proposal we intend to document the rate of bacterial in adults admitted to the hospital with confirmed viral infection. We hypothesize that it is possible to identify patients with documented viral infections who are at low risk for bacterial complications by using clinical and laboratory parameters in combination with new serum biomarkers such as pro-calcitonin. We also believe that physicians will respond appropriately, by withholding or discontinuing antibiotics, in most patients with documented viral illnesses if considered to be at low risk for bacterial complications. In years1-2 we propose to recruit and carefully evaluate ~1000 adults admitted to the hospital with respiratory tract infections during 2 winters for the presence of viral and bacterial infection using standard and new sensitive molecular techniques. We will define a set of clinical and laboratory variables that accurately predict patients with viral infection who are at low risk for bacterial co-infection. In years 3-5, we will prospectively enroll a similar patient population of ~1500 subjects, and identify subjects with documented viral respiratory tract infections and who meet previously defined criteria predicting a low risk of bacterial co-infection. These subjects will be randomized to one of two study arms in a randomized controlled intervention study. Half will enter an "intervention" arm in which physicians receive information regarding the presence of a viral infection and "low bacterial risk status" along with a recommendation to withhold or discontinue antibiotics. The other half will receive "standard care" in which antibiotic use is administered at the discretion of the attending physician who will not receive additional information regarding viral diagnosis or bacterial risk status. The primary analysis will determine if there is a significant reduction in antibiotic use in patients in the intervention group compared to those in the standard care group. Secondary analysis will examine whether the intervention group has improved clinical outcomes (shorter hospitalization, less antibiotic related adverse events, similar or less morbidity and mortality, similar or fewer readmissions for respiratory illness) than the standard care group. PUBLIC HEALTH RELEVANCE This project proposes to decrease unnecessary antibiotic use in patients hospitalized with documented viral respiratory infections. If successful, the major effects on public health would be to limit the spread of antimicrobial resistant bacteria and to decrease health care costs associated antibiotic use and complications in the treatment of respiratory tract infections.

描述（由申请人提供）：急性呼吸道感染是成人入院的最常见原因之一。在临床实践中，几乎普遍施用抗生素，因为通常没有进行特定的微生物诊断。使用敏感分子技术的最新证据表明，这些疾病中很大一部分是由于病毒引起的。尽管病毒感染可能易于二次细菌感染，但实际发病率的研究很差，并且可能被高估了。如果仅针对那些具有真实细菌共感染的患者而不是仅患有病毒感染的患者，则通过减少抗生素相关并发症，抗菌耐药细菌的扩散和整体成本，可以改善患者的整体护理。在此提案中，我们打算记录带有证实病毒感染的成年人的细菌率。我们假设可以通过使用临床和实验室参数与新的血清生物标志物（如促钙蛋白）结合使用临床和实验室参数来鉴定患有病毒感染的患者，这些病毒感染风险较低。我们还认为，在大多数患有病毒疾病的患者中，医生将通过预扣或停止抗生素来做出适当的反应，如果被认为有细菌并发症的风险较低。在1 - 2年中，我们建议在2个冬季使用标准和新的敏感分子技术在2个冬季招募约1000名成年人，并在2个冬季使用呼吸道感染来招募呼吸道感染。我们将定义一组临床和实验室变量，这些变量准确地预测病毒感染患者的细菌共感染风险较低。在3 - 5年内，我们将前瞻性地招募约1500名受试者的患者人群，并确定患有病毒呼吸道感染的受试者，并符合先前定义的标准，以预测细菌共同感染的风险较低。这些受试者将在随机对照干预研究中随机分为两个研究臂之一。一半将进入“干预”部门，其中医生会收到有关存在病毒感染和“低细菌风险状况”的信息，并建议扣留或停止抗生素。另一半将获得“标准护理”，在这些医师的酌情下进行抗生素使用，他们将不会收到有关病毒诊断或细菌风险状况的其他信息。与标准护理组中的患者相比，主要分析将确定干预组患者的抗生素使用量是否显着降低。二级分析将检查干预组是否改善了临床结果（住院时间较短，抗生素相关的不良事件，相似或更少的发病率和死亡率，对呼吸道疾病的再入院或更少）比标准护理组。公共卫生相关性该项目建议减少病毒呼吸道感染的住院患者不必要的抗生素使用。如果成功，对公共卫生的主要影响将是限制抗菌抗性细菌的传播，并降低相关的抗生素使用以及治疗呼吸道感染的并发症的医疗费用。