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

Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques [quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis.

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
• Neonates of pregnancies affected by syphilis ≤ 72 hours of birth

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)

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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