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, California and other locations
Dates
study started
completion around

Description

Summary

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.

Keywords

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

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 California 90095 United States
  • University of Southern California accepting new patients
    Los Angeles California 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