Back to resultsModernizing Perinatal Syphilis Testing
Primary Purpose
Syphilis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
Sponsored by
About this trial
This is an interventional diagnostic trial for Syphilis
Eligibility 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 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
Sites / Locations
- University of Southern CaliforniaRecruiting
- University of California, Los AngelesRecruiting
- Johns Hopkins UniversityRecruiting
- Kennedy Krieger InstituteRecruiting
- Nationwide Children's HospitalRecruiting
- Baylor College of MedicineRecruiting
- Texas Children's HospitalRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- Christus HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06082453
First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT06082453
Brief Title
Modernizing Perinatal Syphilis Testing
Official Title
Modernizing Perinatal Syphilis Testing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
November 30, 2027 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
924 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Description
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
Title
Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Description
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
Title
Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Description
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
Title
Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Description
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
Title
Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
Description
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
Title
Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Description
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
Title
Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Description
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
Title
Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Description
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
Title
Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Description
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
Title
Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
Description
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
Title
Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Description
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.
Time Frame
from 12 weeks gestational age up to 18 months after birth
Title
Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Description
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.
Time Frame
from 12 weeks gestational age up to 18 months after birth
Title
Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Description
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.
Time Frame
from 12 weeks gestational age up to 18 months after birth
Title
Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Description
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.
Time Frame
from 12 weeks gestational age up to 18 months after birth
Title
Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
Description
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.
Time Frame
from 12 weeks gestational age up to 18 months after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Stafford, MD
Phone
(713) 500-6412
Email
Irene.Stafford@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Stafford, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Grubbs, MD
Phone
323-361-6078
Email
Brendan.grubbs@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Alice Stek, MD
Phone
323-226-3353
Email
stek@usc.edu
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Best, PhD
Phone
310-267-1908
Email
kbest@mednet.ucla.edu
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Sheffield, MD
Phone
443-997-0400
Email
jsheffi2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Chris Golden, MD
Phone
410-995-5259
Email
cgolden@jhmi.edu
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Pritchard, PhD
Phone
443-923-9200
Email
pritchard@kennedykrieger.org
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Sanchez
Phone
614-722-4559
Email
pablo.sanchez@nationwidechildrens.org
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Rac, MD
Phone
832-826-7500
Email
martha.rac@bcm.edu
First Name & Middle Initial & Last Name & Degree
Ryan Rochat, MD, PhD
Phone
936-262-0726
Email
rochat@bcm.edu
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Noll, PhD
Phone
832-822-3700
Email
lmnoll@texaschildrens.org
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norma Perez, DO
Phone
832-325-6516
Email
norma.perez@uth.tmc.edu
Facility Name
Christus Health
City
Houston
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Hill, MD
Phone
210-704-3200
Email
james.hill2@christushealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Modernizing Perinatal Syphilis Testing
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