PDF(Pubmed)
Abstract：
UNASSIGNED: In the RESTORE-IMI 2 trial, imipenem/cilastatin/relebactam (IMI/REL) was noninferior to piperacillin/tazobactam in treating hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. This post hoc analysis was conducted to determine independent predictors of efficacy outcomes in the RESTORE-IMI 2 trial, to assist in treatment decision making.
UNASSIGNED: A stepwise multivariable regression analysis was conducted to identify variables that were independently associated with day 28 all-cause mortality (ACM), favorable clinical response at early follow-up (EFU), and favorable microbiologic response at end of treatment (EOT). The analysis accounted for the number of baseline infecting pathogens and in vitro susceptibility to randomized treatment.
UNASSIGNED: Vasopressor use, renal impairment, bacteremia at baseline, and Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II scores ≥15 were associated with a greater risk of day 28 ACM. A favorable clinical response at EFU was associated with normal renal function, an APACHE II score <15, no vasopressor use, and no bacteremia at baseline. At EOT, a favorable microbiologic response was associated with IMI/REL treatment, normal renal function, no vasopressor use, nonventilated pneumonia at baseline, intensive care unit admission at randomization, monomicrobial infections at baseline, and absence of Acinetobacter calcoaceticus-baumannii complex at baseline. These factors remained significant after accounting for polymicrobial infection and in vitro susceptibility to assigned treatment.
UNASSIGNED: This analysis, which accounted for baseline pathogen susceptibility, validated well-recognized patient- and disease-related factors as independent predictors of clinical outcomes. These results lend further support to the noninferiority of IMI/REL to piperacillin/tazobactam and suggests that pathogen eradication may be more likely with IMI/REL.
UNASSIGNED: NCT02493764.
UNASSIGNED: A stepwise multivariable regression analysis was conducted to identify variables that were independently associated with day 28 all-cause mortality (ACM), favorable clinical response at early follow-up (EFU), and favorable microbiologic response at end of treatment (EOT). The analysis accounted for the number of baseline infecting pathogens and in vitro susceptibility to randomized treatment.
UNASSIGNED: Vasopressor use, renal impairment, bacteremia at baseline, and Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II scores ≥15 were associated with a greater risk of day 28 ACM. A favorable clinical response at EFU was associated with normal renal function, an APACHE II score <15, no vasopressor use, and no bacteremia at baseline. At EOT, a favorable microbiologic response was associated with IMI/REL treatment, normal renal function, no vasopressor use, nonventilated pneumonia at baseline, intensive care unit admission at randomization, monomicrobial infections at baseline, and absence of Acinetobacter calcoaceticus-baumannii complex at baseline. These factors remained significant after accounting for polymicrobial infection and in vitro susceptibility to assigned treatment.
UNASSIGNED: This analysis, which accounted for baseline pathogen susceptibility, validated well-recognized patient- and disease-related factors as independent predictors of clinical outcomes. These results lend further support to the noninferiority of IMI/REL to piperacillin/tazobactam and suggests that pathogen eradication may be more likely with IMI/REL.
UNASSIGNED: NCT02493764.
摘要：
■在RESTORE-IMI2试验中，在治疗医院获得性细菌性肺炎/呼吸机相关细菌性肺炎方面,亚胺培南/西司他丁/来巴坦(IMI/REL)不劣于哌拉西林/他唑巴坦.这项事后分析是为了确定RESTORE-IMI2试验中疗效结局的独立预测因素，协助治疗决策。
■进行了逐步多元回归分析，以确定与第28天全因死亡率（ACM）独立相关的变量，早期随访（EFU）的良好临床反应，和治疗结束时良好的微生物反应（EOT）。分析考虑了基线感染病原体的数量和随机治疗的体外敏感性。
■血管加压药的使用，肾功能损害，基线菌血症，急性生理评估和慢性健康评估(APACHE)II评分≥15与第28天ACM的更大风险相关。EFU的良好临床反应与正常肾功能相关，APACHEII评分<15，没有使用血管升压药，基线无菌血症.在EOT,良好的微生物反应与IMI/REL治疗相关，肾功能正常,不使用血管加压药,基线时的非通气性肺炎，随机进入重症监护室，基线时的抗生素感染，基线时不存在钙乙酸不动杆菌-鲍曼不动杆菌复合物。在考虑到多微生物感染和体外对指定治疗的敏感性后，这些因素仍然很重要。
■此分析，这说明了基线病原体易感性，验证公认的患者和疾病相关因素作为临床结局的独立预测因子。这些结果进一步支持了IMI/REL对哌拉西林/他唑巴坦的非劣效性，并表明IMI/REL更有可能根除病原体。
■NCT02493764。
■进行了逐步多元回归分析，以确定与第28天全因死亡率（ACM）独立相关的变量，早期随访（EFU）的良好临床反应，和治疗结束时良好的微生物反应（EOT）。分析考虑了基线感染病原体的数量和随机治疗的体外敏感性。
■血管加压药的使用，肾功能损害，基线菌血症，急性生理评估和慢性健康评估(APACHE)II评分≥15与第28天ACM的更大风险相关。EFU的良好临床反应与正常肾功能相关，APACHEII评分<15，没有使用血管升压药，基线无菌血症.在EOT,良好的微生物反应与IMI/REL治疗相关，肾功能正常,不使用血管加压药,基线时的非通气性肺炎，随机进入重症监护室，基线时的抗生素感染，基线时不存在钙乙酸不动杆菌-鲍曼不动杆菌复合物。在考虑到多微生物感染和体外对指定治疗的敏感性后，这些因素仍然很重要。
■此分析，这说明了基线病原体易感性，验证公认的患者和疾病相关因素作为临床结局的独立预测因子。这些结果进一步支持了IMI/REL对哌拉西林/他唑巴坦的非劣效性，并表明IMI/REL更有可能根除病原体。
■NCT02493764。
