SyphilisSeTPATNCT02059525
Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection
An observational study of Syphilis, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to 15 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- Use of doxycycline, a macrolide antibiotic or a Beta-lactam antibiotic in the preceding 28 days
- Not willing to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection: an Observational Study in Belgium
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.
Read the 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.
- Conditions
- Syphilis
- Keywords
- observational, Belgium
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| syphilis infected | all patients with a new diagnosis of syphilis, receiving treatment at the Institute of Tropical Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
T. Pallidum-specific antigens
Presence/absence and concentration of the T. pallidum-specific antigens
Measured: Baseline
Secondary outcomes (2)
T. pallidum persistence
- pallidum-specific antigens
Measured: 6 months pre-penicillin retreatment
T. pallidum antigens variation
Changes in T. pallidum-specific antigens, Rapid Plasma Reagin (RPR), T. pallidum antigenaemia (TPA) and Syphilis- immunoglobulin M (IgM)
Measured: Any point of suspected treatment failure/reinfection till 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJul 2014
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SyphilisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Chris Kenyon, MD, Principal investigator, Institute of Tropical Medicine, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059525
- Sponsor's protocol ID
- SeTPAT
- Acronym
- SeTPAT
- Status last verified
- Oct 2018
- First submitted
- 6 Feb 2014
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32958482Van 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.
PubMed 30519456Osbak 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.
PubMed 30311792
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection: an Observational Study in Belgium
- ClinicalTrials.gov ID
- NCT02059525
- Acronym / sponsor ID
- SeTPAT / SeTPAT
- Conditions
- Syphilis
- Keywords
- observational, Belgium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- Jul 2014
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| syphilis infected | – | –all patients with a new diagnosis of syphilis, receiving treatment at the Institute of Tropical Medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Use of doxycycline, a macrolide antibiotic or a Beta-lactam antibiotic in the preceding 28 days
- Not willing to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T. Pallidum-specific antigens
Time frame: Baseline
Presence/absence and concentration of the T. pallidum-specific antigens
2 secondary outcomes
T. pallidum persistence
Time frame: 6 months pre-penicillin retreatment
T. pallidum antigens variation
Time frame: Any point of suspected treatment failure/reinfection till 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 32958482Osbak 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.
- Derived from this study: PubMed 30519456Van 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.
- Derived from this study: PubMed 30311792Osbak 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Kenyon, MD principal investigator
Institute of Tropical Medicine, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T. Pallidum-specific antigens (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059525, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.