Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to study the proteomic, immunological, serological and clinical changes associated with pre- and post-treatment syphilis infection in a way that could ultimately lead to the development of a new ELISA and rapid diagnostic test of T. pallidum antigenaemia.

The general aim of this prospecive observational cohort study is thus to quantify a set of target proteins with the highest diagnostic potential for the diagnosis of initial T. pallidum infection and T. pallidum persistence. A test which could directly detect the presence of T. pallidum antigens could represent a considerable advance over currently used tests in the diagnosis of initial syphilis infection, its response to therapy and in the diagnosis of syphilis reinfections. This prospective observational cohort study of HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine, Antwerp.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Finding the Latent Treponema Pallidum

NCT03754517

Syphilis

UNKNOWN

Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System

NCT01543295

Syphilis

WITHDRAWN

Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission

NCT07300254

Syphilis

RECRUITING

Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.

NCT01540227

Syphilis Primary Syphilis Secondary Syphilis +1 more

TERMINATED

Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

NCT03310424

Syphilis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This cohort study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to study the proteomic, immunological, serological and clinical changes associated with pre- and post-treatment syphilis infection in a way that will ultimately lead to the development of a new ELISA and rapid diagnostic test of T. pallidum antigenaemia. The general aim of this observational cohort study is thus to quantify a set of target proteins with the highest diagnostic potential for the diagnosis of initial T. pallidum infection and T. pallidum persistence. A test which could directly detect the presence of T. pallidum antigens could represent a considerable advance over currently used tests in the diagnosis of initial syphilis infection, its response to therapy and in the diagnosis of syphilis reinfections.

This prospective observational cohort study of HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine, Antwerp (ITM). 120 patients with a new diagnosis of syphilis infection who receive treatment for their syphilis at the ITM and give informed consent, will be recruited; based on the current rate of syphilis diagnosis this should take approximately 18 months. Participants will receive a detailed, standardized clinical assessment, fill out a brief behavioural questionnaire and then be treated with therapy for syphilis according to their stage of disease. In addition to the routine tests performed, if and after they consent to participate in this study, they will have their serum analyzed for a number of other immunological markers. A control group will be recruited, consisting of 30 convenience selected patients who are HIV infected but have no evidence of syphilis (Rapid Plasma Reagin, T. pallidum antigenaemia , or clinical evidence that could be suggestive of syphilis infection) are attending the HIV clinic regularly, who were seen in the same month as one of the acute syphilis cases and who consent to take part in the study. The control group will only undergo the investigations planned for the baseline visit.

Noteworthy, it is hoped that the results of the study will also allow to develop and evaluate the utility of a composite diagnostic rule for the diagnosis of syphilis reinfection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syphilis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

syphilis infected

all patients with a new diagnosis of syphilis, receiving treatment at the Institute of Tropical Medicine

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willingness to provide written consent
* Prepared to follow the study schedule
* EITHER a diagnosis of a new episode of syphilis - initial or repeat syphilis (Patients group), OR no evidence of past or present syphilis, defined as no clinical or serological evidence of syphilis (Control group).