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

Syphilis Clinical Trial

— SeTPAT  

Official title:

Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection: an Observational Study in Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059525
• Other study ID #: SeTPAT
• Status: Completed
• Start date: July 2014
• Est. completion date: November 15, 2017

Study information

• Verified date: October 2018
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 15, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Exclusion Criteria:

• Use of doxycycline, a macrolide antibiotic or a Beta-lactam antibiotic in the preceding 28 days

• Not willing to give informed consent

Related Conditions & MeSH terms

• Syphilis

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG)	CT-positives NG-positives	6 months
Primary	T. Pallidum-specific antigens	Presence/absence and concentration of the T. pallidum-specific antigens	Baseline
Secondary	T. pallidum persistence	T. pallidum-specific antigens	6 months pre-penicillin retreatment
Secondary	T. pallidum antigens variation	Changes in T. pallidum-specific antigens, Rapid Plasma Reagin (RPR), T. pallidum antigenaemia (TPA) and Syphilis- immunoglobulin M (IgM)	Any point of suspected treatment failure/reinfection till 24 months

External Links

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