Sánchez-García Miguel, Hammond Jennifer, Yan Jean Li, Kantecki Michal, Ansari Wajeeha, Dryden Matthew
Hospital Clínico San Carlos, Calle del Prof Martín Lagos, Madrid, Spain.
Pfizer, Collegeville, PA, USA.
Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.
Exploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU).
Adults with cSSTI (surface area ≥ 75 cm) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftaroline fosamil (600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5-14 days. Clinical response and ICU length of stay (LOS) within first hospitalization were evaluated in the modified intent-to-treat (MITT) and clinically evaluable (CE) populations; a Cox proportional hazards model identified factors associated with increased hospital LOS.
Overall, 42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n = 32; vancomycin plus aztreonam, n = 10) prior to, or at start of, study treatment. Baseline differences between the ICU and non-ICU populations were indicative of more severe disease in ICU patients; within this subset, there were also some notable imbalances between treatment groups. Clinical cure rates at test-of-cure (ceftaroline fosamil vs. vancomycin plus aztreonam) were generally similar in the non-ICU and ICU subsets (MITT population 79% vs. 79% and 69% vs. 90.0%, respectively; CE population 87% vs. 85% and 80% vs. 89%, respectively). Median ICU LOS was 8 vs. 13 days, respectively. ICU admission was a risk factor predicting increased hospital LOS (P < 0.001).
Clinical outcomes for patients admitted to the ICU were generally similar to non-ICU patients, despite more severe baseline disease, with shorter median treatment duration in the ceftaroline fosamil group. ICU admission was associated with longer hospital LOS. Given the small sample size and unbalanced patient and disease characteristics within the ICU subgroup, differences between treatment groups should be interpreted with caution.
ClinicalTrials.gov identifier, NCT01499277.
在3期COVERS研究中，对入住重症监护病房（ICU）的复杂性皮肤和软组织感染（cSSTI）患者的特征和结局进行探索性分析。
将患有cSSTI（表面积≥75平方厘米）且有全身炎症和/或基础合并症证据的成年人按2:1随机分组，分别接受静脉注射头孢洛林磷霉素（每8小时600毫克[q8h]）或万古霉素（每12小时15毫克/千克）加氨曲南（每8小时1克）治疗5 - 14天。在改良意向性治疗（MITT）和临床可评估（CE）人群中评估首次住院期间的临床反应和ICU住院时间（LOS）；Cox比例风险模型确定与住院LOS增加相关的因素。
总体而言，761例随机分组患者中有42例在研究治疗前或开始时入住ICU（头孢洛林磷霉素组，n = 32；万古霉素加氨曲南组，n = 10）。ICU人群与非ICU人群之间的基线差异表明ICU患者的疾病更严重；在该亚组中，治疗组之间也存在一些明显的不平衡。在非ICU和ICU亚组中，治愈测试时的临床治愈率（头孢洛林磷霉素与万古霉素加氨曲南）总体相似（MITT人群分别为79%对79%和69%对90.0%；CE人群分别为87%对85%和80%对89%）。ICU的中位LOS分别为8天和13天。入住ICU是预测住院LOS增加的危险因素（P < 0.001）。
尽管基线疾病更严重，但入住ICU患者的临床结局与非ICU患者总体相似，头孢洛林磷霉素组的中位治疗持续时间较短。入住ICU与更长的住院LOS相关。鉴于ICU亚组中的样本量小以及患者和疾病特征不平衡，治疗组之间的差异应谨慎解释。
ClinicalTrials.gov标识符，NCT01499277。
