Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial
Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial
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DOI：
10.1016/j.cmi.2016.03.005
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发表时间：
2016-06-01
影响因子：
14.2
通讯作者：
D'Alessandro, U.
中科院分区：
文献类型：
--
作者：
Roca, A.;Oluwalana, C.;D'Alessandro, U.
细菌性败血症仍然是新生儿死亡的主要原因，其中金黄色葡萄球菌、B 族链球菌 (GBS) 和肺炎链球菌被确定为非洲最常见的致病病原体。无症状细菌定植是败血症的中间步骤。我们进行了一项 III 期、双盲、安慰剂对照随机试验，以确定冈比亚待产妇女口服一剂阿奇霉素对产后第 6 天新生儿鼻咽部携带金黄色葡萄球菌、GBS 或肺炎链球菌的影响。研究参与者是在冈比亚西部的一家医疗机构招募的。他们被跟踪了 8 周，并在前 4 周内收集了样本。 2013 年 4 月至 2014 年 4 月期间，我们招募了 829 名妇女，共产下 843 名婴儿，其中 13 名死产。随访期间有 16 名婴儿死亡。没有观察到孕产妇死亡。没有报告与干预相关的严重不良事件。根据意向治疗分析，干预组中新生儿第 6 天鼻咽部携带目标细菌的流行率较低（28.3% 与 65.1% 流行率比 0.43；95% CI 0.36-0.52，p
Bacterial sepsis remains a leading cause of death among neonates with Staphylococcus aureus, group B streptococcus (GBS) and Streptococcus pneumoniae identified as the most common causative pathogens in Africa. Asymptomatic bacterial colonization is an intermediate step towards sepsis. We conducted a phase III, double-blind, placebo-controlled randomized trial to determine the impact of giving one oral dose of azithromycin to Gambian women in labour on the nasopharyngeal carriage of S. aureus, GBS or S. pneumoniae in the newborn at day 6 postpartum. Study participants were recruited in a health facility in western Gambia. They were followed for 8 weeks and samples were collected during the first 4 weeks. Between April 2013 and April 2014 we recruited 829 women who delivered 843 babies, including 13 stillbirths. Sixteen babies died during the follow-up period. No maternal deaths were observed. No serious adverse events related to the intervention were reported. According to the intent-to-treat analysis, prevalence of nasopharyngeal carriage of the bacteria of interest in the newborns at day 6 was lower in the intervention arm (28.3% versus 65.1% prevalence ratio 0.43; 95% CI 0.36-0.52, p