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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
924
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.
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.
University of Southern California
Los Angeles, California, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
RECRUITINGSensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
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)
Time frame: from the time of birth up to 96 hours after birth
Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: from the time of birth up to 72 hours after birth
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 neonatal nontreponemal tiers. These data will be collected as part of standard clinical care.
Johns Hopkins University
Baltimore, Maryland, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGTexas Children's Hospital
Houston, Texas, United States
RECRUITINGThe University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGChristus Health
Houston, Texas, United States
RECRUITINGSensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: from the time of birth up to 72 hours after birth
Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
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.
Time frame: from 12 weeks gestational age up to 18 months after birth
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
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.
Time frame: from 12 weeks gestational age up to 18 months after birth
Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
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.
Time frame: from 12 weeks gestational age up to 18 months after birth
Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
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.
Time frame: from 12 weeks gestational age up to 18 months after birth
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
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.
Time frame: from 12 weeks gestational age up to 18 months after birth