Finding the Latent Treponema Pallidum

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03754517

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Syphilis	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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Finding the Latent Treponema Pallidum of Syphilis With Serofast Status

Actual Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

the reads of treponema pallidum [30 days]
Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All clinical diagnosis of syphilis cases

Exclusion Criteria:

Auto-immune disease (such as SLE)
Lyme disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PekingUMCH	Beijing		China

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator: Jun Li, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03754517

Other Study ID Numbers:

The reaseon of serofast

First Posted:

Nov 27, 2018

Last Update Posted:

Mar 28, 2019

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

syphilis

serofast

Additional relevant MeSH terms:

Syphilis

Treponemal Infections

Study Results

No Results Posted as of Mar 28, 2019