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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD108201 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum | Diagnostic Test | A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | 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) | from the time of birth up to 96 hours after birth |
| Specificity of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Positive predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Negative predictive value of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Area under the receiver operating characteristic (ROC) curve of quantitative polymerase chain reaction (qPCR) assay for detecting T. pallidum | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Stafford, MD | Contact | (713) 500-6412 | Irene.Stafford@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Irene Stafford, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Recruiting | Los Angeles | California | 90007 | United States |
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| Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum | Diagnostic Test | The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother/newborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants. |
|
| Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis | Other | Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven/highly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and neonatal nontreponemal tiers. These data will be collected as part of standard clinical care. |
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| from the time of birth up to 72 hours after birth |
| Sensitivity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Specificity of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Positive predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Negative predictive value of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Area under the receiver operating characteristic (ROC) curve of Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detecting T. pallidum | 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) | from the time of birth up to 72 hours after birth |
| Sensitivity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. | from 12 weeks gestational age up to 18 months after birth |
| Specificity of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. | from 12 weeks gestational age up to 18 months after birth |
| Positive predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. | from 12 weeks gestational age up to 18 months after birth |
| Negative predictive value of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. | from 12 weeks gestational age up to 18 months after birth |
| Area under the receiver operating characteristic (ROC) curve of CDC 2021 STI Treatment Guidelines for diagnosis of syphilis | Clinical data used to diagnose syphilis according the CDC 2021 STI Guidelines will be collected as part of standard clinical care from the time of pregnancy (greater than or equal to 12 weeks gestational age) up to 18 months after birth. | from 12 weeks gestational age up to 18 months after birth |
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Kennedy Krieger Institute | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Christus Health | Recruiting | Houston | Texas | 78130 | United States |
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| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015337 | Multicenter Studies as Topic |
| D002487 | Centers for Disease Control and Prevention, U.S. |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D014492 | United States Public Health Service |
| D014483 | United States Dept. of Health and Human Services |
| D037041 | United States Government Agencies |
| D035082 | Federal Government |
| D006076 | Government |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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