Modernizing Perinatal Syphilis Testing

NCT06082453 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-21-0731R01HD108201
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (15)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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.

  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.

  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.

  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.

  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.

  from 12 weeks gestational age up to 18 months after birth

Study Arms (1)

Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis

EXPERIMENTAL

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

Interventions

Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum DIAGNOSTIC_TEST

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.

Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis

Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum DIAGNOSTIC_TEST

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.

Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis

Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis OTHER

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.

Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (9)

University of Southern California

Los Angeles, California, 90007, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Christus Health

Houston, Texas, 78130, United States

RECRUITING

MeSH Terms

Conditions

Syphilis

Interventions

Multicenter Studies as Topic; Centers for Disease Control and Prevention, U.S.

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; Organizations; Health Care Economics and Organizations

Study Officials

• Irene Stafford, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Stafford, MD

CONTACT

(713) 500-6412; Irene.Stafford@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)