Finding the Latent Treponema Pallidum

Finding the Latent Treponema Pallidum of Syphilis With Serofast Status

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.

Study Overview

• Status: Unknown
• Conditions: Syphilis
• Intervention / Treatment: Diagnostic test: RPR Titer

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Jun Li; Phone Number: 01069151502; Email: lijun35@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • PekingUMCH
    • Contact: Jun Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All syphilis cases.

Description

Inclusion Criteria:

• All clinical diagnosis of syphilis cases

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Serofast status; The syphilitic patients who remain in a serologically positive state after therapy	Diagnostic test: RPR Titer; RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing
Untreated; untreated syphilis cases	Diagnostic test: RPR Titer; RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing
Serological cure; 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.	Diagnostic test: RPR Titer; RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the reads of treponema pallidum	Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis	30 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Jun Li, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: syphilis; serofast
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Syphilis; Treponemal Infections
• Other Study ID Numbers: The reaseon of serofast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No