NCT06082453 · The University of Texas Health Science Center, Houston
Modernizing Perinatal Syphilis Testing
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
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.
DIAGNOSTIC_TEST
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.
OTHER
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 neonatal nontreponemal tiers. These data will be collected as part of standard clinical care.
Primary outcome measures
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: 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
Time frame: 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 quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: 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 Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Time frame: 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
Time frame: 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.
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: 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
Time frame: 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
Time frame: 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 CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
Where
- Los Angeles, California
- Baltimore, Maryland
- Columbus, Ohio
- Houston, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 3, 2025 · Source of record for eligibility and locations