Empiric Antibiotic Therapy for Patients with Pulmonary I

I 型肺病患者的经验性抗生素治疗

• 批准号: 7332161
• 负责人: Naomi P O'Grady
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7332161
• 关键词: Empiric; Antibiotic; Therapy; Patients; Pulmonary

Patients with pulmonary infiltrates receive more than half of the antibiotics prescribed in the ICU. Many of these patients receive antibiotics for suspected, but not proven, respiratory infections. Yet many of these patients with abnormal radiographs actually have a non-infectious etiology. Although pneumonia is the most common hospital acquired infection in ICU patients, it is difficult to diagnose definitively because the diagnosis relies heavily on radiographic findings that correlate poorly with clinical pneumonia. But because of the attributable mortality associated with nosocomial pneumonia, the risk of missing a treatable infection often outweighs the perception of minimal risk antibiotic therapy. Consequently, overuse or inappropriate use of antibiotics for the treatment of suspected pneumonia is widespread in this subset of patients, and the emergence of antimicrobial resistant bacteria as a result of antibiotic overuse is increasingly common. This protocol is designed to determine whether short course empiric antibiotic therapy (3 days of meropenem) for patients with new pulmonary infiltrates can reduce the emergence of antimicrobial resistant organisms compared to a standard course of antibiotic therapy (8 days of therapy with antibiotics of the primary care teams choosing). In addition, it will determine whether hospital length of stay can be reduced, hospital cost can be reduced, while morbidity and mortality of patients will not be affected. This protocol targets patients who have new pulmonary infiltrates, yet are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). Progress Report: Final approval from the BAMSG Steering Committee has been obtained. An IND has been obtained. The NIAID IRB approved this protocol. In addition 5 other sites have obtained IRB approval and have had their site initiation visits from the biostatistics support and coordinating center (BAMBU). Seven sites are awaiting either IRB approval or their site initiation visit. The study is currently enrolling patients with a projected enrollment of 420 patients in total.

肺部浸润性疾病的患者接受了ICU开出的一半以上的抗生素。这些患者中的许多人接受抗生素治疗，以治疗疑似但未经证实的呼吸道感染。然而，这些X光片异常的患者中，有许多人实际上都有非传染性的病因。虽然肺炎是ICU患者最常见的医院获得性感染，但很难做出明确的诊断，因为诊断在很大程度上依赖于与临床肺炎相关性较差的放射学结果。但由于院内肺炎相关的可归因性死亡率，错过可治疗感染的风险往往超过对最低风险抗生素治疗的看法。因此，过度使用或不适当使用抗生素治疗疑似肺炎在这一亚群患者中普遍存在，由于过度使用抗生素而出现的抗菌素耐药性细菌越来越常见。 该方案旨在确定与标准疗程的抗生素治疗(使用初级保健团队选择的8天的抗生素治疗)相比，对新的肺部浸润物患者进行短程经验性抗生素治疗(美罗培南3天)是否可以减少抗菌素耐药微生物的出现。此外，它还将决定是否可以缩短住院时间，降低住院成本，同时不影响患者的发病率和死亡率。该方案针对的是那些有新的肺部浸润物，但肺炎风险较低的患者，这是根据临床肺部感染评分(CPIS)确定的。 进度报告：已获得BAMSG指导委员会的最终批准。已获得IND。NIAID IRB批准了这项协议。此外，其他5个地点已获得IRB批准，并接受了生物统计支持和协调中心(Bambu)的现场启动访问。七个地点正在等待IRB的批准或他们的现场启动访问。这项研究目前正在招募患者，预计总共有420名患者。