| NCT ID | NCT06082453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Syphilis |
| Study Type | INTERVENTIONAL |
| Enrollment | 924 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 924 participants in total. It began in 2023-05-02 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion 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 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 Criteria: * Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive) * Planning to move outside of study prior to ND testing
Contact & Investigator
Irene Stafford, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06082453 clinical trial?
This trial is open to participants of all sexes, up to 45 Years, studying Syphilis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082453 currently recruiting?
Yes, NCT06082453 is actively recruiting participants. Contact the research team at Irene.Stafford@uth.tmc.edu for enrollment information.
Where is the NCT06082453 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Baltimore, United States, Baltimore, United States and 5 additional locations.
Who is sponsoring the NCT06082453 clinical trial?
NCT06082453 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Irene Stafford, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 924 participants.