Modernizing Perinatal Syphilis Testing

The University of Texas System (UT)

Status: Enrolling

Conditions: Syphilis

Treatments: Diagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum; Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum; Other: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06082453

R01HD108201 (U.S. NIH Grant/Contract)

HSC-MS-21-0731

Details and patient eligibility

About

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.

Enrollment: 924 estimated patients

Sex: All

Ages: Under 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

924 participants in 1 patient group

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

Experimental group

Treatment:

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

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

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