Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL): a Blinded, Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,110
- 试验地点
- 1
- 主要终点
- Cumulative incidence of skin and soft tissue infection by 3 months of age in infants
研究概览
简要总结
A trial to assess cumulative incidence of skin and soft tissue infections (SSTI) in infants (by three months of age) born to mothers receiving a single-dose of 2 grams of oral azithromycin during labour (or immediately prior to delivery in the case of caesarean section), compared to infants whose mothers received placebo.
详细描述
PreYIAL is a Phase III, double-blind, randomised, placebo controlled two arm trial of a single 2g dose of azithromycin or placebo, administered to women who have been admitted for delivery of their baby (either following onset of labour or for caesarean section).
The trial includes an estimated 2110 mothers/infant pairs (1055 per arm), with 12 months of follow-up for the mother/infant pair.
A swab-study within the main study involves 940 of the mother/infant pairs enrolled and involves follow-up for bacterial carriage outcomes, for 12 months.These swab-study participants will also be included in assessments of the infant and maternal microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Matched drug and placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Azithromycin
A single 2g dose of Azithromycin
干预措施: Azithromycin 500 mg Oral Tablet x 4 (Drug)
Placebo
Matching Placebo
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Cumulative incidence of skin and soft tissue infection by 3 months of age in infants
时间窗: 3 months
Born to mothers receiving a single dose of 2g Azithromycin during labour. Assessed by history and physical examination at 7 days, 6 weeks and 3 months.
次要结局
- Cumulative incidence of skin and soft tissue infection, and other infections by 12 months of age in infants(Birth to 12 Months)
- Cumulative incidence of maternal infection by 6 weeks and 12 months post-delivery(Delivery to 12 months)
- Cumulative incidence of antibiotic usage by 12 months in infants(Birth to 12 months)
- Cumulative incidence of maternal antibiotic usage by 12 months post-delivery(Delivery to 12 months)
- Number of infant participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1(Birth to 12 months)
- Number of maternal participants with adverse events as assessed by adapted version of CTCAE v5.0 and DAID v2.1(Delivery to 12 months)
- Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus as assessed by real-time quantitative PCR (qPCR) from impetigo swabs(Delivery/birth to 12 months)
- Number of infant and maternal participants with Staphylococcus aureus and/or Group A streptococcus with azithromycin nonsusceptibility cultured from impetigo swabs.(Delivery/birth to 12 months)
- Swab study outcome - Prevalence of bacterial carriage as assessed by real-time quantitative PCR (qPCR)(Delivery/birth to 12 months)
- Swab study outcome - Density of bacterial carriage as assessed by real-time quantitative PCR (qPCR)(Delivery/birth to 12 months)
- Swab study outcome - Risk of antibiotic nonsusceptibility in culture isolates(Delivery/birth to 12 months)
- Swab study outcome - Risk of maternal carriage identified through qPCR of common organisms relevant to Sexually Transmitted Infections (STI)(Delivery/birth to 6 months)
- Swab study outcome - The prevalence of infants with diagnoses that have been associated with microbiome dysbiosis(Delivery/birth to 6 months)