Clinical trial of safety and efficacy of IHN-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants
Clinical trial of safety and efficacy of IHN-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants
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DOI：
10.1016/j.jpeds.2007.04.060
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发表时间：
2007-09-01
影响因子：
5.1
通讯作者：
Hetherington, Seth
中科院分区：
文献类型：
--
作者：
Dejonge, Mitchell;Burchfield, David;Hetherington, Seth
目的探讨来自高滴度抗表皮葡萄球菌和金黄色葡萄球菌表面粘附素抗体供体的静脉注射免疫球蛋白（IGIV）INH-A21对极低出生体重儿（VLBW）迟发性脓毒症（LOS）的预防作用。出生体重为500 - 1250 g的婴儿被随机分配接受最多4剂INH-A21（Veronatee（（R）或安慰剂。主要目的是确定INH-A21与安慰剂预防金黄色葡萄球菌LOS在VLBW infants.Results的安全性和有效性，共有1983名婴儿从95新生儿重症监护病房随机，并收到至少一个剂量的研究药物。接受安慰剂或INH-A21的989名婴儿中有50名（5%）和994名婴儿中有60名（6%）分别发生了金黄色葡萄球菌LOS（P = .34）。凝固酶阴性葡萄球菌（CoNS）、念珠菌属或总死亡率引起的LOS频率无差异。与安慰剂相比，INH-A21输注无统计学显著相关的不良事件。结论INH-A21未能降低早产儿葡萄球菌LOS或念珠菌血症的发生率。
Objective To determine if INH-A21, an intravenous immune globulin (IGIV) derived from donors with high titers of antibody to surface adhesins of Staphylococcus epidermidis and S aureus prevents late-onset sepsis (LOS) in very low birth weight (VLBW) infants.Study design In this double-blind, placebo-controlled study, infants with birth weights 500 to 1250 g were randomized to receive up to four doses of INH-A21 (Veronatee((R))) or placebo. The primary objective was to determine the safety and efficacy of INH-A21 versus placebo for prevention of S aureus LOS in VLBW infants.Results A total of 1983 infants from 95 neonatal intensive care units were randomized, and received at least one dose of study drug. S aureus LOS developed in 50 of 989 (5%) and 60 of 994 (6%) infants who received placebo or INH-A21, respectively (P = .34). No differences were found in the frequencies of LOS caused by coagulase-negative staphylococci (CoNS), Candida spp, or overall mortality. No adverse events were statistically significantly associated with INH-A21 infusions compared with placebo.Conclusion INH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.