Modernizing Perinatal Syphilis Testing

Обзор

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.

Вмешательства

• Диагностический тест Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
  A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants.
• Диагностический тест Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
  The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants.
• Другое Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
  Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and

Первичные конечные точки

• Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 96 hours after birth]
• Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]
• Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum [Срок оценки: from the time of birth up to 72 hours after birth]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
• Planning to move outside of study prior to ND testing

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 9 центров

• University of Southern California — Los Angeles
• University of California, Los Angeles — Los Angeles
• Johns Hopkins University — Baltimore
• Kennedy Krieger Institute — Baltimore
• Nationwide Children's Hospital — Columbus
• Baylor College of Medicine — Houston
• Texas Children's Hospital — Houston
• The University of Texas Health Science Center at Houston — Houston
• … и ещё 1 центр

Идентификаторы

NCT: NCT06082453 · HSC-MS-21-0731 · R01HD108201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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