Modernizing Perinatal Syphilis Testing

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

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

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

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)

This content was sourced from clinicaltrials.gov