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Detection of Treponema pallidum DNA at various body locations

Detection of Treponema pallidum DNA at various body locations - The presence of syphilis bacteria at various body locations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46109
Enrollment
285
Registered
2018-09-26
Start date
2018-11-26
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis Treponema pallidum

Interventions

None listed

Sponsors

GGD Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -18 years or older - Being male and have had sex with males in the past 6 months

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The presence of Tp-DNA load in pharyngeal, rectal, urine and peripheral blood samples; RPR syphilis titer, and infection stage

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)