The diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences

孕妇沙眼衣原体和淋病奈瑟菌的诊断和治疗，防止新生儿不良后果

• 批准号: 10393464
• 负责人: Jeffrey David Klausner
• 金额: $ 19.56万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-22 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10393464
• 关键词: 20 year old; Address; Africa South of the Sahara; Alcohol consumption; Algorithms; Antibiotics; Applications Grants; Behavioral; Biological; Biological Assay; Blindness; Botswana; Characteristics; Chlamydia trachomatis; Clinical; Conjunctivitis; Cornea; Country; Diagnosis; Diagnostic tests; Discipline of obstetrics; Exposure to; First Pregnancy Trimester; Frequencies; Genital; Genitalia; Guidelines; HIV; Health; Immunologic Factors; Immunologic Tests; Incidence; Infant; Infection; Inflammation; Inflammatory; Inflammatory Response; Knowledge; Low Birth Weight Infant; Maternal and Child Health; Measures; Medical; Modeling; Mother-to-child HIV transmission; Mothers; Neisseria gonorrhoeae; Neonatal; Ophthalmia Neonatorum; Outcome; Participant; Patients; Pharmaceutical Preparations; Pneumonia; Policy Maker; Pregnancy; Pregnant Women; Prevalence; Prevention; Public Health Practice; Regimen; Research; Risk; Risk Factors; Sampling; Sexual Partners; Sexually Transmitted Diseases; Specificity; Standardization; Symptoms; Syndrome; Testing; Third Pregnancy Trimester; Tissues; Vertical Disease Transmission; Visit; Woman; Work; adverse outcome; antenatal; antenatal care; cytokine; high risk population; improved; infection burden; infection risk; inflammatory marker; low and middle-income countries; maternal outcome; neglect; neonatal health; neonatal outcome; neonate; pathogen; perinatal outcomes; postnatal; prevent; programs; sociodemographics; transmission process; treatment guidelines

PROJECT ABSTRACT Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are bacterial sexually transmitted infections (STIs), and are neglected causes of adverse neonatal outcomes. According to WHO modelling estimates, CT and NG infections are the most common STIs globally. These infections are even more common among people living with HIV. The risk of vertical transmission during delivery is about 50%. HIV-infected pregnant women with CT and/or NG infections are at increased risk of MTCT of HIV. Other studies on CT and NG infections in neonates are over 20 years old and those infections are not systematically measured in sub- Saharan Africa and are largely unknown. Few countries provide routine antenatal testing. In most countries, the syndromic approach is used, which utilizes an algorithm to classify symptoms into STI syndromes and provide standardized treatment. Syndromic management lacks specificity and causes pregnant women to be unnecessarily exposed to antibiotics, and has low sensitivity, missing asymptomatic infections, putting neonates at risk. Our proposal has three specific aims. Aim 1: We will determine the burden of CT and NG infections and correlates of infection among asymptomatic pregnant women in Gaborone, Botswana by a) using diagnostic testing to estimate the prevalence of CT and NG infections at first and third trimester antenatal visits and postnatal visit and the incidence of infections between those visits; and b) assessing the correlates of infection. Aim 2: Will compare longitudinal neonatal outcomes for pregnant women tested for CT and NG infections with women who received standard antenatal care by a) estimating the frequency of vertical transmission of CT and NG infections and neonatal outcomes and the association with testing and treatment; and b) assessing independent factors that may be predictive of adverse neonatal outcomes. Aim 3: We will assess the burden of infection and markers of inflammatory response to CT and NG infection during pregnancy and associations with vertical transmission of CT and NG by a) testing immunologic factors associated with vertical transmission of CT and NG; b) determining the association between the Xpert® CT/NG assay's pathogen-specific cycle threshold value (Ct) and transmission; and c) evaluating the frequency and distribution of Sample Adequacy Control (SAC) cycle threshold values (Ct) from the Xpert® CT/NG assay, and evaluate any correlations with the transmission of CT/NG to neonates. We will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important neonatal health outcomes, and to evaluate and understand biological correlates of transmission. This study seeks to generate evidence to inform a larger R01 grant application.

项目摘要 沙眼衣原体（CT）和淋病奈瑟菌（NG）是细菌性性传播 感染（STI），是被忽视的新生儿不良后果的原因。根据WHO模型 据估计，CT和NG感染是全球最常见的性传播感染。这些感染更为常见 艾滋病病毒感染者中。分娩期间垂直传播的风险约为50%。hiv感染 感染沙眼衣原体和/或淋球菌的孕妇发生母婴传播艾滋病毒的风险增加。其他关于CT和 新生儿中的NG感染超过20岁，并且这些感染未在低于20岁的人群中进行系统测量。 撒哈拉非洲，大部分是未知的。 很少有国家提供常规产前检查。在大多数国家，采用综合征方法， 其利用算法将症状分类为STI综合征并提供标准化治疗。 综合征管理缺乏特异性，导致孕妇不必要地暴露于 抗生素，敏感性低，遗漏无症状感染，使新生儿处于危险之中。 我们的建议有三个具体目标。目标1：我们将确定CT和NG感染的负担， 博茨瓦纳哈博罗内无症状孕妇感染的相关性，a）使用诊断 在妊娠早期和妊娠晚期产前访视时进行检测，以估计CT和NG感染的患病率， 产后就诊和这些就诊之间的感染发生率;和B）评估感染的相关性。 目的2：比较CT和NG感染检测孕妇的纵向新生儿结局， 接受标准产前护理的妇女，a）估计CT垂直传播的频率， NG感染和新生儿结果以及与测试和治疗的关联;和B）评估 独立的因素，可能是预测不良新生儿结局。目标3：我们将评估 妊娠期CT和NG感染的炎症反应标志物及其相关性 通过a）测试与垂直传播相关的免疫因素 B）确定Xpert® CT/NG检测试剂盒的病原体特异性周期 阈值（Ct）和透射率;以及c）评估样品重复性的频率和分布 Xpert® CT/NG检测试剂盒的质控品（SAC）循环阈值（Ct），并评价与 CT/NG向新生儿的传播。 我们将提供证据，以帮助评估测试对垂直传播和临床的影响。 重要的新生儿健康结果，并评估和了解传播的生物相关性。这 研究旨在提供证据，为更大的R 01赠款申请提供信息。