评估的有效性和安全性Eravacycline vs厄他培南在调查复杂腹腔感染革兰氏阴性感染治疗Eravacycline(点燃1)试验:一个随机临床试验。
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李Solomkin J,埃文斯D, Slepavicius, P,沼泽,蔡L, Sutcliffe JA,角P
评估的有效性和安全性Eravacycline vs厄他培南在调查复杂腹腔感染革兰氏阴性感染治疗Eravacycline(点燃1)试验:一个随机临床试验。
JAMA Surg. 2017 3月1,152 (3):224 - 232。doi: 10.1001 / jamasurg.2016.4237。
- PubMed ID
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27851857 (在PubMed]
- 文摘
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重要性:Eravacycline是小说,完全与体外合成fluorocycline抗生素四环素类的活动对临床重要的革兰氏阴性,革兰氏阳性需氧,和兼性细菌包括大部分的耐头孢菌素、氟喹诺酮类原料药,beta-lactam / beta-lactamase抑制剂耐药菌株和特拉肠杆菌科,最厌氧病原体。目的:评估的有效性和安全性eravacycline与厄他培南在成人住院患者复杂腹腔感染(cIAIs)。设计、设置和参与者:这是第三阶段,随机、双盲、多中心的研究,评估的有效性和安全性eravacycline相比,厄他培南cIAI患者需要手术或介入治疗。test-of-cure评价进行了25到31天后第一剂量的研究药物和后续的访问进行了38 - 50天后第一剂量研究的药物。所有患者加入了这项研究住院。五百四十一名患者参与了这个研究;270名患者被随机分配接受eravacycline, 271名患者被随机分配接受厄他培南。病人必须满足以下所有条件:住院cIAI需要干预;18岁或以上;证据的系统性炎症反应; pain caused by cIAI; able to provide informed consent; and diagnosis of cIAI with sonogram or radiographic imaging or visual confirmation. Analyses were done in intent-to-treat and evaluable populations. Interventions: Patients received eravacycline, 1.0 mg/kg every 12 hours, or ertapenem, 1.0 g every 24 hours, for a minimum of four 24-hour dosing cycles. Main Outcomes and Measures: Clinical outcome assessments were made at the end of treatment, test of cure, and follow-up visits and were classified as clinical cure, clinical failure, or indeterminate/missing. Results: In total, 541 patients were randomly assigned to treatment: 270 in the eravacycline group and 271 in the ertapenem group. The mean ages were 54.9 years and 55.4 years for the eravacycline and ertapenem groups, respectively. Most patients were white (263 of 270 patients [97.4%] in the eravacycline group and 260 of 271 patients [95.9%] in the ertapenem group). For the microbiological intent-to-treat population, the rates of clinical cure at the test-of-cure visit were 86.8% in the eravacycline group and 87.6% in the ertapenem group. The difference in clinical cure rates between the groups was -0.80% (95% CI, -7.1% to 5.5%), meeting the prespecified noninferiority margin and allowing for statistical noninferiority of eravacycline to ertapenem to be declared for this study. Both study drugs were well tolerated. Conclusions and Relevance: Overall, eravacycline demonstrated noninferiority to ertapenem for the treatment of patients with cIAI. Trial Registration: Clinicaltrials.gov Identifier: NCT01844856.
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