Finding the Latent Treponema Pallidum

Syphilis Clinical Trial

Official title:

Finding the Latent Treponema Pallidum of Syphilis With Serofast Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754517
• Other study ID #: The reaseon of serofast
• Status: Recruiting
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Jun Li
• Phone: 01069151502
• Email: lijun35[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All clinical diagnosis of syphilis cases

Exclusion Criteria:

• Auto-immune disease (such as SLE)

• Lyme disease

Related Conditions & MeSH terms

• Syphilis

Intervention

Diagnostic Test:
• RPR Titer
RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing

Locations

Country	Name	City	State
China	PekingUMCH	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the reads of treponema pallidum	Using the Next-Generation Sequencing to test specific genome of treponema pallidum for syphilis	30 days