Back to resultsThe Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings
Primary Purpose
Syphilis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Benzathine Penicillin G
Sponsored by
About this trial
This is an interventional treatment trial for Syphilis
Eligibility Criteria
Inclusion Criteria
1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
Exclusion Criteria:
- Pregnant woman
- Known allergy to penicillin
- RPR titers were found to be 1:8 or less
Sites / Locations
- Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Molecular subtyping (14d/f) of Treponema pallidum
Molecular subtyping (others) of Treponema pallidum
Arm Description
Benzathine Penicillin G treatment
Benzathine Penicillin G treatment
Outcomes
Primary Outcome Measures
rapid plasma regain titer
Secondary Outcome Measures
Full Information
NCT ID
NCT02871505
First Posted
August 9, 2016
Last Updated
November 15, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02871505
Brief Title
The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
5. Study Description
Brief Summary
The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Molecular subtyping (14d/f) of Treponema pallidum
Arm Type
Experimental
Arm Description
Benzathine Penicillin G treatment
Arm Title
Molecular subtyping (others) of Treponema pallidum
Arm Type
Experimental
Arm Description
Benzathine Penicillin G treatment
Intervention Type
Drug
Intervention Name(s)
Benzathine Penicillin G
Primary Outcome Measure Information:
Title
rapid plasma regain titer
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
Exclusion Criteria:
Pregnant woman
Known allergy to penicillin
RPR titers were found to be 1:8 or less
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, M.D.
Phone
86-010-69151504
Email
lijun35@hotmail.com
Facility Information:
Facility Name
Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D.
Phone
86-010-69151504
Email
lijun35@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings
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