Finding the Latent Treponema Pallidum

NCT ID: NCT03754517

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Syphilis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Serofast status

The syphilitic patients who remain in a serologically positive state after therapy

RPR Titer

Intervention Type DIAGNOSTIC_TEST

RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing

Untreated

untreated syphilis cases

RPR Titer

Intervention Type DIAGNOSTIC_TEST

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.

RPR Titer

Intervention Type DIAGNOSTIC_TEST

RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing

Interventions

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RPR Titer

RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All clinical diagnosis of syphilis cases

Exclusion Criteria

* Auto-immune disease (such as SLE)
* Lyme disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Li

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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PekingUMCH

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Li

Role: CONTACT

01069151502

Facility Contacts

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Jun Li

Role: primary

Other Identifiers

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The reaseon of serofast

Identifier Type: -

Identifier Source: org_study_id

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