Finding the Latent Treponema Pallidum

• Conditions: Syphilis
• Interventions: Diagnostic Test: RPR Titer

• Registration Number: NCT03754517
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, srum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Detailed Description

Some syphilitic patients remain in a serologically positive state after the recommended therapy. Whether a serofast state could represent a persistent low-level infection by Treponema pallidum is still unknown. The possibility that persistent nontreponemal antibodies after treatment represent persistence of Treponema pallidum was raised by some investigators. The investigators use the Next-Generation Sequencing to test blood plasma, serum, cerebrospinal fluid, aqueous humor, lymph nodes, skin lesion, saliva, semen,milk of serofast patient and other positive and negative controls.

Study Timeline

• Study Start: 2016-08
• Status Verified: 2018-11
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All clinical diagnosis of syphilis cases

Exclusion Criteria

• Auto-immune disease (such as SLE)
• Lyme disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serological cure	RPR Titer	In the early syphilis patients, at 6 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer. In the late syphilis patients, at 12 months following treatment, a serological cure was defined as either a negative RPR or ≥2 dilution (4-fold) decrease in the RPR titer.
Serofast status	RPR Titer	The syphilitic patients who remain in a serologically positive state after therapy
Untreated	RPR Titer	untreated syphilis cases

Primary Outcome Measures

Name	Time	Method
the reads of treponema pallidum	30 days	Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis

Trial Locations

Locations (1)

PekingUMCH; 🇨🇳 Beijing, China