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

November 15, 2018 updated by: Jun Li, Peking Union Medical College Hospital
The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rapid plasma regain titer
Time Frame: 6 months after treatment
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-2016079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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