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: 7215798
• 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/7215798
• 关键词: beta lactam antibiotic; drug administration rate /duration; drug resistance; drug screening /evaluation; hospital length of stay; hospital patient care; human subject; human therapy evaluation; microorganism disease chemotherapy; nosocomial infection control; nosocomial infections; outcomes research; patient oriented research; pneumonia; respiratory disorder chemotherapy; respiratory infections

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 [12], 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 (10 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. The study has undergone scientific review and is pending IRB review at the Clinical Center. The process of obtaining an IND is underway. The IND is expected by October 31. Ten sites have been selected based on information obtained by survey. An investigators meeting is scheduled for mid-December.

肺浸润患者接受ICU处方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疑似但未经证实的呼吸道感染。然而，许多X线片异常的患者实际上有非感染性病因。虽然肺炎是ICU患者中最常见的医院获得性感染[12]，但很难明确诊断，因为诊断严重依赖于与临床肺炎相关性较差的放射学检查结果。但由于与医院获得性肺炎相关的归因死亡率，错过可治疗感染的风险往往超过对最小风险抗生素治疗的认识。因此，过度使用或不适当使用抗生素治疗疑似肺炎在这部分患者中很普遍，并且由于抗生素过度使用而导致的抗菌素耐药菌的出现越来越常见。 本方案旨在确定与标准疗程抗生素治疗（使用初级保健团队选择的抗生素治疗10天）相比，新发肺浸润患者的短期经验性抗生素治疗（美罗培南治疗3天）是否可以减少抗生素耐药微生物的出现。此外，这亦会决定是否可以缩短住院时间，减低住院成本，而不影响病人的发病率和死亡率。该方案针对患有新发肺浸润但使用临床肺部感染评分（CPIS）确定的肺炎风险较低的患者。 进展报告：已获得BAMSG指导委员会的最终批准。本研究已接受科学审查，并正在等待临床中心的IRB审查。获得IND的过程正在进行中。IND预计将于10月31日发布。根据调查获得的信息，选择了10个地点。调查人员会议定于12月中旬举行。