Status:
RECRUITING
Modernizing Perinatal Syphilis Testing
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Syphilis
Eligibility:
All Genders
Up to 45 years
Phase:
NA
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 no...
Eligibility Criteria
Inclusion
- 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
- Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
- Planning to move outside of study prior to ND testing
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
924 Patients enrolled
Trial Details
Trial ID
NCT06082453
Start Date
May 2 2023
End Date
November 30 2027
Last Update
November 3 2025
Active Locations (9)
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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