Treponema Pallidum Infection

2

Review clinical trials related to Treponema Pallidum Infection. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.

This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.

Participants needed: 1,000
Trial details
Age: 13+Biological sex: AllType: ObservationalSponsor: American Laboratory Products CompanyUpdated: Feb 11, 2026Locations: 6
Eligibility criteria

Male, Female, or Other(s) [+6]

Patients currently being treated with antibiotics or completed a course of antib... [+3]

Status: Not yet recruiting

Improving Maternal and Child Health Through Point-of-care STI Testing

The goal of this clinical trial is to learn if point-of-care tests (POCTs) for sexually transmitted infections (STIs) improve the timely treatment of syphilis, chlamydia, gonorrhea, and trichomonas in pregnant women. It will also learn about the feasibility, acceptability, and cost-effectiveness of implementing POCTs in a large safety-net hospital setting. The main questions it aims to answer are: * Do POCTs reduce delays in STI treatment compared with standard laboratory-based testing? * What barriers, facilitators, and processes affect POCT implementation in prenatal and obstetric care? * What are the costs and cost-effectiveness of POCTs compared with standard testing? Participants will: * Complete a baseline survey and receive either POCTs (fingerstick blood draw or vaginal swab) or standard laboratory STI testing. * If diagnosed with an STI, complete a follow-up survey approximately one month later. * Stakeholders (providers, hospital leadership, and public health officials) will complete interviews to inform implementation strategies.

Participants needed: 756
Trial details
Biological sex: FemaleType: InterventionalSponsor: Emory UniversityUpdated: Dec 18, 2025Locations: 1
Eligibility criteria

Syphilis, CT, NG, and TV indicated at first PNC visit [+16]

Indicated for syphilis test: negative RPR test during this pregnancy [+6]