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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02871505
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. rapid plasma regain titer [6 months after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China	Beijing		China

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Li, Principal Investigator, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT02871505
• Other Study ID Numbers: PUMCH-2016079
• First Posted: Aug 18, 2016
• Last Update Posted: Nov 16, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Syphilis; Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine

Study Results

No Results Posted as of Nov 16, 2018