Congenital Syphilis Clinical Trial
Official title:
Point-Of-Care Testing for Congenital Syphilis in Mothers and Newborns: A Proof of Concept Study
A dramatic rise in syphilis has been recently reported in the US between 2000-2017, which was followed also by a dramatic rise in congenital syphilis (CS). In 2017 there were 918 CS cases reported in the United States, including 64 syphilitic stillbirths. In 2017, California (CA) had one of the highest syphilis rates among women and this was accompanied by a dramatic increase in CS cases. Approximately 40% of CS cases in the United States occurred from maternal infections acquired late in gestation, missed by current-early gestation only-prenatal screening. More frequent prenatal screening late in gestation is urgently needed. However, cost considerations and operational logistic limitations preclude implementation even in high risk regions. There is an urgent need for widespread implementation of more frequent prenatal screening using alternative cost-saving screening approaches. The Syphilis-Health-Check (SHC) point-of-care (POC) test is a well validated POC-test that is already commercially available in the US, is approved by the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived. POC prenatal syphilis screening late in gestation using a well validated POC-test (in addition to the standard early gestation-screening with laboratory-based tests) could provide a cost-saving complementary alternative that could benefit patients, mitigate the higher cost associated with more frequent testing, overcome operational limitations and contribute to the elimination of CS. Moreover, POC-neonatal and placental screening could provide an additional complementary safeguard approach to decrease missed/delayed CS diagnoses.
Given the dramatic rise in syphilis that has been recently reported in the United States in
the recent years (between 2000-2017) there is an urgent need for widespread implementation of
more frequent prenatal syphilis screening using alternative cost-saving screening approaches.
The Syphilis-Health-Check (SHC) point-of-care (POC) test is a well validated POC-test that is
already commercially available in the United States, is approved by the Federal Drug
Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA)-waived.
Hypotheses: a) Point-Of-Care (POC) prenatal syphilis screening late in gestation using a well
validated POC-test (in addition to the standard early gestation-screening with lab-based
tests) could provide a cost-saving complementary alternative that could benefit patients,
mitigate the higher cost associated with the need for more frequent syphilis screening,
overcome operational limitations and contribute to the elimination of CS. b) POC-neonatal
screening can provide additional complementary safeguard approach to decrease missed/delayed
CS diagnoses. POC-neonatal syphilis screening can be used as a rapid screening tool to
capture/probe all neonatal cases who would need immediate medical attention and further
investigation and workup to rule out (or rule-in accordingly) suspected/probable CS.
Specific Aim 1: Validate the diagnostic accuracy of SHC-POC-test in late gestation (24-28
weeks): a) against standard laboratory based syphilis treponemal tests (TT)/and
non-treponemal tests (NTT) in prenatal-care clinic settings and b) also against clinical
diagnoses of maternal syphilis requiring treatment during gestation (co-primary endpoint).
Specific aim 2: Test the feasibility of POC-prenatal screening (secondary endpoint) and
efficacy of POC-prenatal screening to decrease the incidence of CS in a high risk region,
through prompt diagnosis (and treatment accordingly) of maternal syphilis cases that need
immediate treatment (to prevent mother-to -child transmission) (co-primary endpoint).
Specific Aim 3: Evaluate the feasibility of POC-neonatal screening and POC-placental
screening and the concordance of the results between late gestation maternal, neonatal and
placental POC-test results. (Proof of concept; secondary endpoints).
Study design: (a) Prospective cohort study in the Santa Clara Valley Medical Center (SCVMC),
San Jose, CA over a 3 yr study period with enrollment of pregnant women at 24-28 weeks (wks)
gestational age (GA), presenting for their routine clinic visit at 24-28 wks for their
glucose tolerance test (GTT). SCVMC recently introduced as a new standard of care rescreening
for syphilis of all pregnant women at 24-28 wks with TT/NTTs, bundled to the venipuncture for
the Glucose Tolerance Test (GTT). During this clinic visit, the syphilis POC-testing will be
done via a fingerstick in clinic, while the standard lab-based syphilis screening will be
done via venipuncture in the lab (as part of the new standard of care). (b) Proof-of-concept
prospective cohort substudy to test the feasibility of neonatal POC-testing (whole-blood
collected via heel stick, bundled with the routine newborn screening for inborn errors of
metabolism at 24-48 hours of life) and placental-POC-testing.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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N/A |