An interventional study of Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum and Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum in Syphilis, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 9 sites in United States. Open to participants aged Up to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-03.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Diagnostic
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 924 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum · Diagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum · Other: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
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.
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.
Sensitivity 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
Sensitivity 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
Plan to share: No
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Started May 2023 (actual). Primary completion is estimated for Nov 2027, 54 months after the start.
Of 25 interventional studies with no phase under Syphilis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 54 months is above that.
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