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NCT Number: NCT06082453

Modernizing Perinatal Syphilis Testing

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.

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Key information

Conditions

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

Age range

Up to 45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Stafford, MD

CONTACT

[email protected]

(713) 500-6412

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2023
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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