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: 7658798
• 负责人: Ann R Falsey
• 金额: $ 42.17万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-18 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7658798
• 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住院的最常见原因之一。在临床实践中，抗生素几乎普遍使用，因为通常无法进行特定的微生物诊断。最近使用敏感分子技术的证据表明，这些疾病中有很大一部分是由病毒引起的。虽然病毒感染可能易导致继发性细菌感染，但对实际发生率的研究很少，可能被高估。如果抗生素的使用仅针对那些真正的细菌合并感染的患者，而不是仅针对那些病毒感染的患者，则通过减少抗生素相关并发症，抗菌药物耐药菌的传播和总体成本，整体患者护理将得到改善。在本提案中，我们打算记录确诊病毒感染的住院成人中的细菌感染率。我们假设，通过使用临床和实验室参数结合新的血清生物标志物（如降钙素原），有可能识别出有记录的病毒感染患者，这些患者的细菌并发症风险较低。我们还认为，如果认为细菌并发症的风险较低，医生会对大多数有记录的病毒性疾病患者做出适当的反应，暂停或停用抗生素。在第1 -2年，我们建议招募约1000名在2个冬季因呼吸道感染入院的成人，并使用标准和新的敏感分子技术仔细评估是否存在病毒和细菌感染。我们将定义一组临床和实验室变量，这些变量可以准确预测细菌合并感染风险低的病毒感染患者。在第3-5年，我们将前瞻性入组约1500例受试者的相似患者人群，并确定记录有病毒性呼吸道感染且符合先前定义的预测细菌合并感染风险较低的标准的受试者。这些受试者将在随机对照干预研究中随机分配至两个研究组之一。其中一半将进入“干预”组，医生将收到有关病毒感染和“低细菌风险状态”的信息沿着暂停或停止使用抗生素的建议。另一半将接受“标准护理”，其中抗生素的使用由主治医生决定，他们不会收到有关病毒诊断或细菌风险状态的额外信息。主要分析将确定与标准治疗组相比，干预组患者的抗生素使用是否显著减少。次要分析将检查干预组是否比标准治疗组改善了临床结局（住院时间更短，抗生素相关不良事件更少，发病率和死亡率相似或更低，因呼吸系统疾病再次入院相似或更少）。公共卫生相关性本项目旨在减少因病毒性呼吸道感染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生素耐药性细菌的传播，并减少与抗生素使用和呼吸道感染治疗并发症相关的医疗保健费用。