Modernizing Perinatal Syphilis Testing
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis
|
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.
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
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Neonates of pregnancies affected by syphilis ≤ 72 hours of birth
Exclusion Criteria:
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Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
-
Planning to move outside of study prior to ND testing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90007 |
| 2 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 3 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 4 | Kennedy Krieger Institute | Baltimore | Maryland | United States | 21205 |
| 5 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 6 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 7 | Texas Children's Hospital | Houston | Texas | United States | 77030 |
| 8 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
| 9 | Christus Health | Houston | Texas | United States | 78130 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Irene Stafford, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-21-0731
- R01HD108201