Recruiting

qPCR & TMA

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06082453

Conditions

Syphilis

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

Interventions

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

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

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

Study Details

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

Study ID

NCT06082453

Start date

May 2, 2023

Status verified date

Oct, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

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

Enrollment

924 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

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.

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.

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 measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Irene Stafford, MD

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

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

Contacts

Brendan Grubbs, MD

323-361-6078Brendan.grubbs@med.usc.edu

Alice Stek, MD

323-226-3353stek@usc.edu

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Karin Best, PhD

310-267-1908kbest@mednet.ucla.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Jeanne Sheffield, MD

443-997-0400jsheffi2@jhmi.edu

Chris Golden, MD

410-995-5259cgolden@jhmi.edu

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Alison Pritchard, PhD

443-923-9200pritchard@kennedykrieger.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Pablo Sanchez

614-722-4559pablo.sanchez@nationwidechildrens.org

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Martha Rac, MD

832-826-7500martha.rac@bcm.edu

Ryan Rochat, MD, PhD

936-262-0726rochat@bcm.edu

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Lisa Noll, PhD

832-822-3700lmnoll@texaschildrens.org

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Norma Perez, DO

832-325-6516norma.perez@uth.tmc.edu

Christus Health

Recruiting

Houston, Texas, United States, 78130

Contacts

James Hill, MD

210-704-3200james.hill2@christushealth.org

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-11-03.