NCT02059525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

February 6, 2014

Last Update Submit

October 10, 2018

Conditions

Syphilis

Keywords

observationalBelgium

Outcome Measures

Primary Outcomes (1)

  • T. Pallidum-specific antigens

    Presence/absence and concentration of the T. pallidum-specific antigens

    Baseline

Secondary Outcomes (2)

  • T. pallidum persistence

    6 months pre-penicillin retreatment

  • T. pallidum antigens variation

    Any point of suspected treatment failure/reinfection till 24 months

Other Outcomes (1)

  • Accuracy of screening for Chlamydia trachomatis (CT) and Neisseria gonorrhoea (NG)

    6 months

Study Arms (1)

syphilis infected

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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).

You may not qualify if:

  • Use of doxycycline, a macrolide antibiotic or a Beta-lactam antibiotic in the preceding 28 days
  • Not willing to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

Related Publications (3)

  • Osbak KK, Tsoumanis A, De Baetselier I, Van Esbroek M, Smet H, Kenyon CR, Crucitti T. Role of IgM testing in the diagnosis and post-treatment follow-up of syphilis: a prospective cohort study. BMJ Open. 2020 Sep 21;10(9):e035838. doi: 10.1136/bmjopen-2019-035838.

    PMID: 32958482DERIVED

  • Van Raemdonck GA, Osbak KK, Van Ostade X, Kenyon CR. Needle lost in the haystack: multiple reaction monitoring fails to detect Treponema pallidum candidate protein biomarkers in plasma and urine samples from individuals with syphilis. F1000Res. 2018 Mar 19;7:336. doi: 10.12688/f1000research.13964.2. eCollection 2018.

    PMID: 30519456DERIVED

  • Osbak KK, Van Raemdonck GA, Dom M, Cameron CE, Meehan CJ, Deforce D, Ostade XV, Kenyon CR, Dhaenens M. Candidate Treponema pallidum biomarkers uncovered in urine from individuals with syphilis using mass spectrometry. Future Microbiol. 2018 Oct;13(13):1497-1510. doi: 10.2217/fmb-2018-0182. Epub 2018 Oct 12.

    PMID: 30311792DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma and urine

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Chris Kenyon, MD

    Institute of Tropical Medicine, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 11, 2014

Study Start

July 1, 2014

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

BE(1)