Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens.
Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens.
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DOI：
10.1093/cid/ciq031
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发表时间：
2011-01-01
期刊：
影响因子：
--
通讯作者：
ATTAIN Study Group
中科院分区：
文献类型：
--
作者：
Rubinstein E;Lalani T;Corey GR;Kanafani ZA;Nannini EC;Rocha MG;Rahav G;Niederman MS;Kollef MH;Shorr AF;Lee PC;Lentnek AL;Luna CM;Fagon JY;Torres A;Kitt MM;Genter FC;Barriere SL;Friedland HD;Stryjewski ME;ATTAIN Study Group
两项方法学相同的双盲研究结果表明，根据治疗革兰氏阳性病原体引起的医院获得性肺炎的临床反应，特拉万星不劣于万古霉素。背景。 Telavancin 是一种针对革兰氏阳性病原体的脂糖肽杀菌剂。方法。 开展了两项方法学相同的双盲研究（0015 和 0019），研究对象为革兰氏阳性病原体，特别是耐甲氧西林金黄色葡萄球菌 (MRSA) 引起的医院获得性肺炎 (HAP) 患者。患者按 1:1 的比例随机分配至特拉万星（每 24 小时 10 mg/kg）或万古霉素（每 12 小时 1 g），持续 7-21 天。主要终点是随访/治愈测试访视时的临床反应。结果。 共有 1503 名患者被随机分配并接受研究药物治疗（所有接受治疗的人群）。在所有接受治疗的人群中，特拉万星与万古霉素的治愈率分别为 58.9% 和 59.5%（差异的 95% 置信区间 [CI] 为 –5.6% 至 4.3%）。在临床可评估的汇总人群 (n = 654) 中，特拉万星的治愈率为 82.4%，万古霉素的治愈率为 80.7%（差异的 95% CI 为 –4.3% 至 7.7%）。特拉万星治疗对单微生物金黄色葡萄球菌感染患者的治愈率较高，而对 MRSA 感染患者的治愈率相当；在革兰氏阳性/革兰氏阴性混合感染的患者中，万古霉素组的治愈率较高。治疗组之间不良事件的发生率和类型相当。研究 0015 中特拉万星治疗与万古霉素治疗患者的死亡率分别为 21.5% 与 16.6%（差异 95% CI，–0.7% 至 10.6%），研究 0019 中死亡率分别为 18.5% 与 20.6%（差异 95% CI，–7.8% 至 3.5%）。血清肌酐水平升高更为常见特拉万星组（16% vs 10%）。结论。 研究的主要终点得到满足，表明根据治疗革兰氏阳性病原体引起的 HAP 的临床反应，特拉万星不劣于万古霉素。
The results from two methodologically identical double-blind studies indicate that telavancin is noninferior to vancomycin based on clinical response in the treatment of hospital-acquired pneumonia due to Gram-positive pathogens. Background. Telavancin is a lipoglycopeptide bactericidal against gram-positive pathogens. Methods. Two methodologically identical, double-blind studies (0015 and 0019) were conducted involving patients with hospital-acquired pneumonia (HAP) due to gram-positive pathogens, particularly methicillin-resistant Staphylococcus aureus (MRSA). Patients were randomized 1:1 to telavancin (10 mg/kg every 24 h) or vancomycin (1 g every 12 h) for 7–21 days. The primary end point was clinical response at follow-up/test-of-cure visit. Results. A total of 1503 patients were randomized and received study medication (the all-treated population). In the pooled all-treated population, cure rates with telavancin versus vancomycin were 58.9% versus 59.5% (95% confidence interval [CI] for the difference, –5.6% to 4.3%). In the pooled clinically evaluable population (n = 654), cure rates were 82.4% with telavancin and 80.7% with vancomycin (95% CI for the difference, –4.3% to 7.7%). Treatment with telavancin achieved higher cure rates in patients with monomicrobial S. aureus infection and comparable cure rates in patients with MRSA infection; in patients with mixed gram-positive/gram-negative infections, cure rates were higher in the vancomycin group. Incidence and types of adverse events were comparable between the treatment groups. Mortality rates for telavancin-treated versus vancomycin-treated patients were 21.5% versus 16.6% (95% CI for the difference, –0.7% to 10.6%) for study 0015 and 18.5% versus 20.6% (95% CI for the difference, –7.8% to 3.5%) for study 0019. Increases in serum creatinine level were more common in the telavancin group (16% vs 10%). Conclusions. The primary end point of the studies was met, indicating that telavancin is noninferior to vancomycin on the basis of clinical response in the treatment of HAP due to gram-positive pathogens.
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影响因子：
4.9
作者：
Pace, JL;Krause, K;Kaniga, K
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Kaniga, K
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5.2
作者：
Leuthner, Kimberly D.;Cheung, Chrissy M.;Rybak, Michael J.
通讯作者：
Rybak, Michael J.