Modernizing Perinatal Syphilis Testing
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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 novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
University of Southern California
RECRUITING
Los Angeles
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Kennedy Krieger Institute
RECRUITING
Baltimore
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Texas
Baylor College of Medicine
RECRUITING
Houston
Christus Health
RECRUITING
Houston
Texas Children's Hospital
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Irene Stafford, MD
Irene.Stafford@uth.tmc.edu
(713) 500-6412
Time Frame
Start Date: 2023-05-02
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 924
Treatments
Experimental: Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)