Clinical trial NCT06082453: Modernizing Perinatal Syphilis Testing
Official title: Modernizing Perinatal Syphilis Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Syphilis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-13
Enrollment: 924
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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
* Neonates of pregnancies affected by syphilis ≤ 72 hours of birth

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

Primary outcomes:
measure: Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
timeFrame: from the time of birth up to 96 hours after birth
measure: Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum
timeFrame: from the time of birth up to 72 hours after birth
measure: Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
timeFrame: from 12 weeks gestational age up to 18 months after birth
measure: Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
timeFrame: from 12 weeks gestational age up to 18 months after birth
measure: Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
timeFrame: from 12 weeks gestational age up to 18 months after birth
measure: Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
timeFrame: from 12 weeks gestational age up to 18 months after birth
measure: Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis
timeFrame: from 12 weeks gestational age up to 18 months after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Christus Health
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Irene Stafford, MD
role: PRINCIPAL_INVESTIGATOR
References: