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Modernizing Perinatal Syphilis Testing
NCT06082453 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06082453
The ClinicalTrials.gov registry entry for NCT06082453 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 924 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06082453 reports 9 study locations spanning 4 distinct geographic areas — top geographies include Texas, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06082453?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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