NCT03754517

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 28, 2019

Status Verified

November 1, 2018

Enrollment Period

3.3 years

First QC Date

November 15, 2018

Last Update Submit

March 26, 2019

Conditions

Syphilis

Keywords

syphilisserofast

Outcome Measures

Primary Outcomes (1)

  • the reads of treponema pallidum

    Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis

    30 days

Study Arms (3)

Serofast status

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

Diagnostic Test: RPR Titer

Untreated

untreated syphilis cases

Diagnostic Test: RPR Titer

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

Interventions

RPR TiterDIAGNOSTIC_TEST

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

Serofast statusSerological cureUntreated

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All syphilis cases.

You may qualify if:

  • All clinical diagnosis of syphilis cases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PekingUMCH

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

body fluid

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Jun Li

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Li

CONTACT

01069151502lijun35@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

November 27, 2018

Study Start

August 1, 2016

Primary Completion

November 1, 2019

Study Completion

December 1, 2019

Last Updated

March 28, 2019

Record last verified: 2018-11

Locations

CN(1)