NCT02871505

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

August 9, 2016

Last Update Submit

November 15, 2018

Conditions

Syphilis

Outcome Measures

Primary Outcomes (1)

  • rapid plasma regain titer

    6 months after treatment

Study Arms (2)

Molecular subtyping (14d/f) of Treponema pallidum

EXPERIMENTAL

Benzathine Penicillin G treatment

Drug: Benzathine Penicillin G

Molecular subtyping (others) of Treponema pallidum

EXPERIMENTAL

Benzathine Penicillin G treatment

Drug: Benzathine Penicillin G

Interventions

Benzathine Penicillin GDRUG
Molecular subtyping (14d/f) of Treponema pallidumMolecular subtyping (others) of Treponema pallidum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Syphilis

Interventions

Penicillin G

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Jun Li, M.D.

CONTACT

86-010-69151504lijun35@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 18, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

CN(1)