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NCT06082453 · ClinicalTrials.gov registry record · NA
Modernizing Perinatal Syphilis Testing
A NA study of Syphilis, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- NA
- Development phase
- 924
- Enrollment target
- 9
- Study locations
NCT06082453: Recruiting NA study of Syphilis, sponsored by The University of Texas Health Science Center, Houston.
NCT06082453 is a NA study of Syphilis that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 924 participants, above the 120-participant average among 6 other Syphilis trials with a reported enrollment target (670% higher). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06082453, a NA study of Syphilis, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- NA
- Development phase
- 924 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
Samples will be collected from participants during the following time periods: from the time of birth to up to 72 hours after birth (for neonates) from time of birth up to 96 hours after birth (for mothers)
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum
- DIAGNOSTIC_TEST Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum
- OTHER Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis
Study Locations (9)
Texas
- Baylor College of Medicine - Houston
- Texas Children's Hospital - Houston
- The University of Texas Health Science Center at Houston - Houston
- Christus Health - Houston
California
- University of Southern California - Los Angeles
- University of California, Los Angeles - Los Angeles
Maryland
- Johns Hopkins University - Baltimore
- Kennedy Krieger Institute - Baltimore
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 924 participants |
| Start Date | 2023-05-02 |
| Est. Completion | 2027-11-30 |
| Phase | NA |
What NCT06082453 shows while recruiting
NCT06082453 is an interventional study that assigns participants to a tested intervention. The registered 924 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 6 other Syphilis trials with a reported enrollment target (670% higher).
The record links to 1 condition, with Syphilis appearing as the primary indexed condition, and to 3 interventions - of which Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum is the first listed.
NCT06082453 lists 9 locations in 4 states (Texas, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT06082453 about?
NCT06082453 is a clinical study titled "Modernizing Perinatal Syphilis Testing". 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 syphil...
What is the current status of trial NCT06082453?
This trial is currently recruiting. It is a NA study. The enrollment target is 924 participants. The study started on 2023-05-02. Estimated completion is 2027-11-30.
What conditions does trial NCT06082453 study?
This clinical trial studies the following conditions: Syphilis.
What interventions are being tested in trial NCT06082453?
The interventions under investigation include: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum (DIAGNOSTIC_TEST), Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum (DIAGNOSTIC_TEST), Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis (OTHER).
Who is sponsoring clinical trial NCT06082453?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06082453 being conducted?
This trial has 9 study locations across California, Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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