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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis.
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A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis.

机译：预防葡萄球菌败血症的单克隆抗体（pagibaximab）的随机研究。

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BACKGROUND: Pagibaximab, a human chimeric monoclonal antibody developed against lipoteichoic acid, was effective against staphylococci preclinically and seemed safe and well tolerated in phase 1 studies. OBJECTIVE: To evaluate the clinical activity, pharmacokinetics, safety, and tolerability of weekly pagibaximab versus placebo infusions in very low birth weight neonates. PATIENTS AND METHODS: A phase 2, randomized, double-blind, placebo-controlled study was conducted at 10 NICUs. Patients with a birth weight of 700 to 1300 g and 2 to 5 days old were randomly assigned to receive 3 once-a-week pagibaximab (90 or 60 mg/kg) or placebo infusions. Blood was collected for pharmacokinetics, bacterial killing, and safety analyses. Adverse event and clinical outcome data were collected. RESULTS: Eighty-eight patients received pagibaximab at 90 (n = 22) or 60 (n = 20) mg/kg or placebo (n = 46). Groups were not different in demography, mortality, or morbidity. Pagibaximab demonstrated linear pharmacokinetics, a 14.5-day half-life, and nonimmunogenicity. Definite staphylococcal sepsis occurred in 0%, 20%, and 13% (P < .11) and nonstaphylococcal sepsis occurred in 0%, 10%, and 15% (P < .15) of patients in the 90 mg/kg, 60 mg/kg, and placebo groups, respectively. In all patients with staphylococcal sepsis, estimated or observed pagibaximab levels were <500 mug/mL (target level) at infection. CONCLUSIONS: Three once-a-week 90 or 60 mg/kg pagibaximab infusions, in high-risk neonates, seemed safe and well tolerated. No staphylococcal sepsis occurred in infants who received 90 mg/kg. Target levels were only consistently achieved after 2 to 3 doses. Dose optimization should enhance protection.
机译：背景：Pagibaximab是一种针对脂磷壁酸的人类嵌合单克隆抗体，在临床前对葡萄球菌有效，并且在1期研究中似乎安全且耐受性良好。目的：评估极低出生体重新生儿每周服用帕格昔布单抗与安慰剂相比的临床活性，药代动力学，安全性和耐受性。患者和方法：在10个重症监护病房进行了2期，随机，双盲，安慰剂对照研究。出生体重为700至1300 g，2至5天的患者被随机分配接受每周3次帕格巴昔单抗（90或60 mg / kg）或安慰剂输注。收集血液用于药代动力学，细菌杀灭和安全性分析。收集不良事件和临床结果数据。结果：88例患者接受了90（n = 22）或60（n = 20）mg / kg帕格巴昔单抗或安慰剂（n = 46）。人群的人口统计学，死亡率或发病率无差异。 Pagibaximab表现出线性的药代动力学，14.5天的半衰期和非免疫原性。在90 mg / kg，60的患者中，明确的葡萄球菌败血症发生率分别为0％，20％和13％（P <.11），非葡萄球菌败血症发生率分别为0％，10％和15％（P <.15）。 mg / kg和安慰剂组。在所有葡萄球菌败血症患者中，感染时帕吉巴昔单抗的估计或观察水平低于500杯/ mL（目标水平）。结论：高危新生儿每周三次90或60 mg / kg Pagibaximab输注似乎安全并且耐受良好。接受90 mg / kg的婴儿未发生葡萄球菌败血症。仅在2至3剂后才能始终达到目标水平。剂量优化应加强保护。

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