Modernizing Perinatal Syphilis Testing

Syphilis Clinical Trial

Official title:

Modernizing Perinatal Syphilis Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082453
• Other study ID #: HSC-MS-21-0731
• Secondary ID: R01HD108201
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: November 30, 2027

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Irene Stafford, MD
• Phone: (713) 500-6412
• Email: Irene.Stafford[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 924
• Est. completion date: November 30, 2027
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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

• Neonates of pregnancies affected by syphilis = 72 hours of birth

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

Related Conditions & MeSH terms

• Syphilis

Intervention

Diagnostic Test:
• Quantitative 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.
• Aptima 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.

Other:
• Center 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
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	Christus Health	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	from the time of birth up to 96 hours after birth
Primary	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)	from the time of birth up to 72 hours after birth
Primary	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)	from the time of birth up to 72 hours after birth
Primary	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)	from the time of birth up to 72 hours after birth
Primary	Area under the receiver operating characteristic (ROC) curve 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)	from the time of birth up to 72 hours after birth
Primary	Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) 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)	from the time of birth up to 72 hours after birth
Primary	Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) 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)	from the time of birth up to 72 hours after birth
Primary	Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) 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)	from the time of birth up to 72 hours after birth
Primary	Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) 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)	from the time of birth up to 72 hours after birth
Primary	Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) 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)	from the time of birth up to 72 hours after birth
Primary	Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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.	from 12 weeks gestational age up to 18 months after birth
Primary	Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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.	from 12 weeks gestational age up to 18 months after birth
Primary	Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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.	from 12 weeks gestational age up to 18 months after birth
Primary	Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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.	from 12 weeks gestational age up to 18 months after birth
Primary	Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis	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.	from 12 weeks gestational age up to 18 months after birth