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

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ClinicalTrials.gov Identifier: NCT02059525
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

Study Description
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Brief 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.


Condition or disease
Syphilis

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection: an Observational Study in Belgium
Study Start Date : July 2014
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

Groups and Cohorts
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Group/Cohort
syphilis infected
all patients with a new diagnosis of syphilis, receiving treatment at the Institute of Tropical Medicine


Outcome Measures
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Primary Outcome Measures :
  1. T. Pallidum-specific antigens [ Time Frame: Baseline ]
    Presence/absence and concentration of the T. pallidum-specific antigens


Secondary Outcome Measures :
  1. T. pallidum persistence [ Time Frame: 6 months pre-penicillin retreatment ]
    T. pallidum-specific antigens

  2. T. pallidum antigens variation [ Time Frame: Any point of suspected treatment failure/reinfection till 24 months ]
    Changes in T. pallidum-specific antigens, Rapid Plasma Reagin (RPR), T. pallidum antigenaemia (TPA) and Syphilis- immunoglobulin M (IgM)


Other Outcome Measures:
  1. Accuracy of screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG) [ Time Frame: 6 months ]
    CT-positives NG-positives


Biospecimen Retention:   Samples Without DNA
serum, plasma and urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a new diagnosis of syphilis infection who receive treatment for their syphilis at the Institute of Tropical Medicine (ITM), and a control group , consisting of patients who are HIV infected but have no evidence of syphilis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059525


Locations
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Belgium
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
University Hospital, Antwerp
Investigators
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Principal Investigator: Chris Kenyon, MD Institute of Tropical Medicine, Belgium
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02059525    
Other Study ID Numbers: SeTPAT
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Institute of Tropical Medicine, Belgium:
observational
Belgium
Additional relevant MeSH terms:
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Syphilis
Infection
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
 Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female