Detection of Treponema pallidum DNA at various body locations

Completed

• Conditions: Syphilis; Treponema pallidum; 10004018

• Registration Number: NL-OMON46109
• Lead Sponsor: GGD Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 285

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The presence of Tp-DNA load in pharyngeal, rectal, urine and peripheral blood<br /><br>samples; RPR syphilis titer, and infection stage</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sensitivity, specificity, predictive values (positive and negative) and area<br /><br>under the curve (AUC) of the Tp-PCR assay in pharyngeal, rectal, urine and<br /><br>blood samples.</p><br>