Finding the Latent Treponema Pallidum | NCT03754517

Studies
Finding the Latent Treponema Pallidum

NCT03754517

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Mar 28, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Syphilis

Interventions

RPR Titer

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 15, 2018

First Submission Date that Met QC Criteria

Nov 26, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
RPR Titer	Diagnostic Test	RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing	Serofast status Serological cure Untreated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All clinical diagnosis of syphilis cases

Exclusion Criteria:

Auto-immune disease (such as SLE)
Lyme disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

All syphilis cases.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Li	Contact	01069151502		lijun35@hotmail.com

Overall Officials

Name	Affiliation	Role
Jun Li	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PekingUMCH	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D013587	Syphilis

Ancestor Terms

ID	Term
D014211	Treponemal Infections
D013145	Spirochaetales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections

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