Modernizing Perinatal Syphilis Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 924
- 试验地点
- 18
- 主要终点
- Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
研究概览
简要总结
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
- •Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis
排除标准
- •Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- •Planning to move outside of study prior to ND testing
结局指标
主要结局
Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
时间窗: from the time of birth up to 96 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
时间窗: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
时间窗: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
时间窗: from the time of birth up to 72 hours after birth
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
时间窗: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
时间窗: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
时间窗: from 12 weeks gestational age up to 18 months after birth
Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth.
次要结局
未报告次要终点
研究者
Irene Stafford
Associate Professor
The University of Texas Health Science Center, Houston