Modernizing Perinatal Syphilis Testing

a study on Sexually Transmitted Infections Syphilis

Summary

Eligibility
for people ages up to 45 years (full criteria)
Location
at Los Angeles 5368361, California 5332921 and other locations
Dates
study started
study ends around

Description

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.

Keywords

Syphilis, Multicenter Studies as Topic, U.S. Centers for Disease Control and Prevention, Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum, Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum, Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis

Eligibility

You can join if…

Open to people ages up to 45 years

  • 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

You CAN'T join if...

  • Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
  • Planning to move outside of study prior to ND testing

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • University of Southern California accepting new patients
    Los Angeles 5368361 California 5332921 90007 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
The University of Texas Health Science Center, Houston
ID
NCT06082453
Study Type
Interventional
Participants
Expecting 924 study participants
Last Updated