Modernizing Perinatal Syphilis Testing
ConditionSyphilis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 45
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Treatments tested in this trial
- Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
- Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
- Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
Treatment groups
924 Participants
are divided into 1 treatment groupSponsors and collaborators
The University of Texas Health Science Center, Houston
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov