Modernizing Perinatal Syphilis Testing

The University of Texas Health Science Center, Houston

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.

Eligibility

Age range: Up to 45 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

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.

Locations (9)

University of Southern California
Los Angeles, California
Brendan.grubbs@med.usc.edu 323-361-6078
University of California, Los Angeles
Los Angeles, California
kbest@mednet.ucla.edu 310-267-1908
Johns Hopkins University
Baltimore, Maryland
jsheffi2@jhmi.edu 443-997-0400
Kennedy Krieger Institute
Baltimore, Maryland
pritchard@kennedykrieger.org 443-923-9200
Nationwide Children's Hospital
Columbus, Ohio
pablo.sanchez@nationwidechildrens.org 614-722-4559
Baylor College of Medicine
Houston, Texas
martha.rac@bcm.edu 832-826-7500