Modernizing Perinatal Syphilis Testing

Description

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.

Conditions

Syphilis

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Study Overview

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Study Details

Study overview

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.

Modernizing Perinatal Syphilis Testing

Modernizing Perinatal Syphilis Testing

Condition
Syphilis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90007

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21205

Baltimore

Kennedy Krieger Institute, Baltimore, Maryland, United States, 21205

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Houston

Texas Children's Hospital, Houston, Texas, United States, 77030

Houston

The University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Houston

Christus Health, Houston, Texas, United States, 78130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)
  • * Planning to move outside of study prior to ND testing

Ages Eligible for Study

to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Irene Stafford, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

2027-11-30