(1) To determine the presence of T. pallidum DNA as proxy for the infectiousness of peripheral blood, urethral, anal and pharyngeal mucosa in infectious syphilis. (2) To evaluate T. pallidum polymerase chain reaction test (Tp-PCR) to diagnose…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of Tp-DNA load in pharyngeal, rectal, urine and peripheral blood
samples; RPR syphilis titer, and infection stage
Secondary outcome
Sensitivity, specificity, predictive values (positive and negative) and area
under the curve (AUC) of the Tp-PCR assay in pharyngeal, rectal, urine and
blood samples.
Background summary
Syphilis rates worldwide are on the rise, in the Western world especially among
men who have sex with men (MSM). In an era with pre-exposure prophylaxis
against HIV infection and subsequent risk compensation it is feared that the
number of infections may become even higher. Syphilis is routinely diagnosed on
clinical findings and serologic tests. However in the early stages of the
infection, serology may be false negative, and syphilis may be asymptomatic.
This poses challenges in the diagnosis and missed infections may lead to onward
transmission and late sequelae. Moreover, the mode of transmission, especially
in asymptomatic patients, is not well understood.
Study objective
(1) To determine the presence of T. pallidum DNA as proxy for the
infectiousness of peripheral blood, urethral, anal and pharyngeal mucosa in
infectious syphilis.
(2) To evaluate T. pallidum polymerase chain reaction test (Tp-PCR) to diagnose
infectious syphilis, when applied on urine, peripheral blood and on anal and
pharyngeal mucosal samples.
(3) To obtain DNA samples from more patients with syphilis in order to improve
studies on molecular epidemiology.
Study design
A cohort study
Study burden and risks
This study is developed to get a better understanding of transmission and
diagnostics in early syphilis. There are no additional risks for participants.
In participants with an negative syphilis serology or negative Tp-PCR
ulceration result who have an early incubating diagnosis, this study may be of
benefit, since it would have been missed with the routine screening algorithm.
If Tp-PCR on mucosal swabs, urine or peripheral blood has added value,
implementation will be considered for routine practice.
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Listed location countries
Age
Inclusion criteria
-18 years or older
- Being male and have had sex with males in the past 6 months
Exclusion criteria
Exclusion criteria
- Use of antibiotics within 4 weeks prior to inclusion
- Use of antibiotics within 12 weeks after inclusion in participants with positive Tp-PCR results
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66419.018.18 |