Modernizing Perinatal Syphilis Testing

Conditions

• Syphilis

Eligibility Criteria

Sex

ALL

Age

N/A - 45 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

May 2, 2023

Status verified

Oct 2025

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

924 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

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

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 ]

Central Contacts

• Irene Stafford, MD
  (713) 500-6412
  [email protected]

Locations (9)

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