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) 是细菌性传播疾病 根据世界卫生组织的模型，感染（性传播感染）是导致新生儿不良结局的被忽视的原因。 据估计，CT 和 NG 感染是全球最常见的性传播感染。 艾滋病毒感染者在分娩过程中发生垂直传播的风险约为 50%。 CT 和/或 NG 感染的孕妇发生 HIV 母婴传播的风险增加。 新生儿 NG 感染发生在 20 岁以上，并且这些感染并未在亚组中进行系统测量。 撒哈拉非洲地区基本上不为人所知。 很少有国家提供常规产前检查。大多数国家采用综合征方法。 它利用算法将症状分类为性传播感染综合症并提供标准化治疗。 症状管理缺乏特异性，导致孕妇不必要地暴露于 抗生素敏感性低，漏检无症状感染者，使新生儿面临风险。 我们的提案有三个具体目标 1：我们将确定 CT 和 NG 感染的负担以及 a) 使用诊断方法确定博茨瓦纳哈博罗内无症状孕妇感染的相关性 进行检测以估计妊娠早期和晚期产前检查时 CT 和 NG 感染的流行率，以及 产后访视和两次访视之间的感染发生率；b) 评估感染的相关性。 目标 2：将接受 CT 和 NG 感染检测的孕妇的纵向新生儿结局与 接受标准产前护理的妇女，通过 a) 估计 CT 垂直传播的频率和 NG 感染和新生儿结局以及与检测和治疗的关联；b) 评估； 目标 3：我们将评估可能预测不良新生儿结局的独立因素。 妊娠期间 CT 和 NG 感染的感染和炎症反应标志物及其关联 通过 a) 测试与垂直传播相关的免疫因素来检测 CT 和 NG 的垂直传播 CT 和 NG；b) 确定 Xpert® CT/NG 检测的病原体特异性循环之间的关联 阈值 (Ct) 和传输；以及 c) 评估样本充足性的频率和分布 从 Xpert® CT/NG 检测中控制 (SAC) 循环阈值 (Ct)，并评估与 CT/NG 向新生儿的传播。 我们将提供证据来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学相关性。 研究旨在生成证据，为更大的 R01 拨款申请提供信息。

项目成果

Evaluating the diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences in Gaborone, Botswana: protocol for the Maduo study.

评估博茨瓦纳哈博罗内孕妇沙眼衣原体和淋病奈瑟菌的诊断和治疗，以预防新生儿不良后果：Maduo 研究方案。

• 发表时间: 2022-03-07
• 影响因子: 3.7
• 作者: Wynn, Adriane;Mussa, Aamirah;Ryan, Rebecca;Hansman, Emily;Simon, Selebaleng;Bame, Bame;Moreri;Ramogola;Klausner, Jeffrey D;Morroni, Chelsea
• 通讯作者: Morroni, Chelsea

High Cure Rate Among Pregnant Women in a Chlamydia trachomatis and Neisseria gonorrhoeae Testing and Treatment Intervention Study in Gaborone, Botswana.

博茨瓦纳哈博罗内的沙眼衣原体和淋病奈瑟菌检测和治疗干预研究中孕妇的治愈率很高。

• 发表时间: 2023-02-01
• 影响因子: 3.1
• 作者: Mussa, Aamirah;Wynn, Adriane;Ryan, Rebecca;Babalola, Chibuzor;Simon, Selebaleng;Ramontshonyana, Kehumile;Tamuthiba, Lefhela;Ndlovu, Neo;Moshashane, Neo;Klausner, Jeffrey D;Morroni, Chelsea
• 通讯作者: Morroni, Chelsea

Case series and literature review of chlamydial ophthalmia neonatorum in Botswana.

博茨瓦纳新生儿衣原体眼炎病例系列和文献综述。

• 发表时间: 2023-10
• 影响因子: 1.4
• 作者: Yang, Kevin;Babalola, Chibuzor M;Mussa, Aamirah;Ryan, Rebecca;Wynn, Adriane;Simon, Selebaleng;Bame, Bame;Morroni, Chelsea;Klausner, Jeffrey D
• 通讯作者: Klausner, Jeffrey D

Discrete Plasma Cytokine Profiles Among Pregnant Women in Botswana by Chlamydia trachomatis Infection, Human Immunodeficiency Virus Status, and Gestational Age.

博茨瓦纳孕妇沙眼衣原体感染、人类免疫缺陷病毒状态和孕龄的离散血浆细胞因子谱。

• 发表时间: 2022-09-28
• 作者: Babalola, Chibuzor M;Siebert, Janet C;Kallapur, Suhas G;Maecker, Holden T;Rosenberg;Hansman, Emily;Wynn, Adriane;Mussa, Aamirah;Ryan, Rebecca;Simon, Selebaleng;Morroni, Chelsea;Klausner, Jeffrey D
• 通讯作者: Klausner, Jeffrey D

Prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infection and associated factors among asymptomatic pregnant women in Botswana.

博茨瓦纳无症状孕妇沙眼衣原体和淋病奈瑟菌感染的患病率及相关因素。

• 发表时间: 2023-06
• 影响因子: 1.4
• 作者: Mussa, Aamirah;Wynn, Adriane;Ryan, Rebecca;Babalola, Chibuzor M;Hansman, Emily;Simon, Selebaleng;Bame, Bame;Tamuthiba, Lefhela;Ramontshonyana, Kehumile;Ndlovu, Neo;Moshashane, Neo;Masole, Maitumelo;Klausner, Jeffrey D;Morroni, Chelsea
• 通讯作者: Morroni, Chelsea