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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 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.

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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.

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

FieldValue
Enrollment Target 924 participants
Start Date 2023-05-02
Est. Completion 2027-11-30
Phase NA

What the Registry Record Tells You About NCT06082453

The ClinicalTrials.gov registry entry for NCT06082453 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 924 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 6 other Syphilis trials with a reported enrollment target (670% higher). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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