SIP Study

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.

 

 

---

Trial Information

Target Recruitment:

• 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.

Sponsor: The University of Texas Health Science Center, Houston
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Duration of Study: May 2, 2023 – November 30, 2027

---

Study Principal Investigator

---

Links

Protocol
ClinicalTrials.gov
Parent Information Sheet: English | Spanish