Modernizing Perinatal Syphilis Testing
- Conditions
- Syphilis
- Interventions
- Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidumDiagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidumOther: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
- Registration Number
- NCT06082453
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 924
- 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
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis - Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum - Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum -
- Primary Outcome Measures
Name Time Method 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)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)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)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.
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)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.
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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Kennedy Krieger Institute
🇺🇸Baltimore, Maryland, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Christus Health
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States