Modernizing Perinatal Syphilis Testing

October 30, 2025 updated by: Irene Stafford, The University of Texas Health Science Center, Houston
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

924

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
      • Los Angeles, California, United States, 90007
        • Recruiting
        • University of Southern California
        • Contact:
        • Contact:
          • Alice Stek, MD
          • Phone Number: 323-226-3353
          • Email: stek@usc.edu
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Contact:
      • Baltimore, Maryland, United States, 21205
    • Ohio
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Contact:
          • Ryan Rochat, MD, PhD
          • Phone Number: 936-262-0726
          • Email: rochat@bcm.edu
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 78130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
from the time of birth up to 96 hours after birth
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
from the time of birth up to 72 hours after birth
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.
from 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.
from 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.
from 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.
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
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.
from 12 weeks gestational age up to 18 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Irene Stafford, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-21-0731
  • R01HD108201 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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