Innovative Strategies for Perinatal Infectious Risk Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,600
- 试验地点
- 6
- 主要终点
- Presence of Streptococcus B
研究概览
简要总结
The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.
详细描述
Early-onset neonatal sepsis (EOS) is a major global public health challenge. Prevention during pregnancy and delivery, early diagnosis and treatment of perinatal infections are essential to avoid EOS. Risk factors for include prematurity, maternal Group B streptococcus (GBS) colonization, premature rupture of membranes (PROM), and chorioamnionitis. Screening and intrapartum antimicrobial prophylaxis administered to GBS-colonized women has reduced early onset GBS infections. However, other pathogens are frequently involved in EOS following preterm PROM and preterm birth (PTB), such as Gram-negative bacteria and Staphylococci, which are not covered by penicillin prophylaxis. The prevalence of neonatal infection arising from antibiotic-resistant bacteria is increasing, thus the challenge is to eliminate the widespread unnecessary use of broad-spectrum antibiotics to treat non-infected infants, while recognizing when antibiotics are truly needed. Rapid diagnostic test(s) to detect and quantify specifically pathogens in vaginal samples, could be a major breakthrough. Several rT- PCR ( reverse Transcriptase Polymerase Chain Reaction) tests are on the market, however so far no test is able to detect, quantify and characterize in terms of antibiotic resistance and virulence genes, a range of pathogens.
A novel multiplex platform, using microfluidics technology, is under development by Elvesys, Inc in France. This platform will be able to offer results within 15 minutes on-site.
In addition, the study of the vaginal microbiome may identify signatures associated with a risk of maternal-fetal infection, particularly in case of PROM or PTB. Advanced sequencing technology and metagenomics will be used to characterize these signatures, and may lead to further markers to be included in the point-of-care test. Finally, biomarkers of inflammation will be detected, including IL-6 (Interleukin).
In this study, the InSPIRe platform will be compared in the laboratory to conventional microbiological and immunological detection.
Four groups of pregnant women will be recruited in prospective cohorts : uneventful pregnancies, term PROM, preterm labor and preterm PROM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Pregnant woman,
- •Gestational age over 22 SA,
- •Patient agreeing to sign informed consent,
- •Patient aged at least 18 years old,
- •Patient with health insurance,
- •Singleton, twin or multiple pregnancy.
排除标准
- •Fetal death or non-viable fetus,
- •maternal age under 18,
- •Patient unable to express her consent,
- •Patient under guardianship.
结局指标
主要结局
Presence of Streptococcus B
时间窗: until 20 weeks
次要结局
- Maternal fetal infection(until 20 weeks + 3 days)
- Maternal local biomarkers definition(until 20 weeks)
- Vaginal dysmorphism(until 20 weeks)
- Bacteriological signature definition(until 20 weeks)
- Highlighting specific virulence markers(until 20 weeks)
- A positive bacteriological result in the vaginal sample(until 20 weeks)
- Antibiotic resistance(until 20 weeks)
- Chorioamnionitis(until 20 weeks)