Syphilis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTQuantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
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.
DIAGNOSTIC_TESTAptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
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.
OTHERCenter for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 45 Years
Healthy volunteers
No
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 OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth * Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | from the time of birth up to 96 hours after birth | 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) |
| Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | from the time of birth up to 72 hours after birth | 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) |
| Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | from 12 weeks gestational age up to 18 months after birth | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. |
| Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | from 12 weeks gestational age up to 18 months after birth | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. |
| Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | from 12 weeks gestational age up to 18 months after birth | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. |
| Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | from 12 weeks gestational age up to 18 months after birth | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. |
| Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | from 12 weeks gestational age up to 18 months after birth | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. |
Countries
United States
Contacts
Primary ContactIrene Stafford, MD
Outcome results
None listed