Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum

    Diagnostic test

    A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants.

  • Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum

    Diagnostic test

    The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants.

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

    Other intervention

    Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and neonatal nontreponemal tiers. These data will be collected as part of standard clinical care.

Treatment groups

924 Participants
are divided into 1 treatment group
Group A: Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilisExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum

Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)

Time frame
from the time of birth up to 96 hours after birth
2

Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum

Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)

Time frame
from the time of birth up to 72 hours after birth
3

Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum

Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)

Time frame
from the time of birth up to 72 hours after birth
4

Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum

Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)

Time frame
from the time of birth up to 72 hours after birth

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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