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The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings

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ClinicalTrials.gov Identifier: NCT02871505
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Li, Peking Union Medical College Hospital

Brief Summary:
The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum

Condition or disease Intervention/treatment Phase
Syphilis Drug: Benzathine Penicillin G Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Molecular subtyping (14d/f) of Treponema pallidum
Benzathine Penicillin G treatment
Drug: Benzathine Penicillin G
Experimental: Molecular subtyping (others) of Treponema pallidum
Benzathine Penicillin G treatment
Drug: Benzathine Penicillin G



Primary Outcome Measures :
  1. rapid plasma regain titer [ Time Frame: 6 months after treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis

Exclusion Criteria:

  1. Pregnant woman
  2. Known allergy to penicillin
  3. RPR titers were found to be 1:8 or less

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871505


Contacts
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Contact: Jun Li, M.D. 86-010-69151504 lijun35@hotmail.com

Locations
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China
Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China Recruiting
Beijing, China
Contact: Jun Li, M.D.    86-010-69151504    lijun35@hotmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Jun Li, Principal Investigator, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02871505    
Other Study ID Numbers: PUMCH-2016079
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents