Modernizing Perinatal Syphilis Testing

Not Applicable

Recruiting

• Conditions: Syphilis

• Registration Number: NCT06082453
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-30
• Last Update Posted: 2025-11-03
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 924

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum	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 quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum	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	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	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	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	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	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	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 CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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 Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum	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 CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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 Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum	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	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	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	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.

Trial Locations

Locations (9)

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

Christus Health; 🇺🇸 Houston, Texas, United States