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One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

Primary Purpose

Syphilis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Benzathine Penicillin G

About this trial

This is an interventional treatment trial for Syphilis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
A rapid plasma reagin (RPR) test was positive, with a titer were 1:4 or higher. In addition, Treponema pallidum particle agglutination assay and/or fluorescent treponemal antibody absorption test were reactive.

Exclusion Criteria:

1.Patients who were pregnancy, known allergy to penicillin, use of antibiotics active against syphilis during the preceding six months for symptomatic cases or during the preceding two years for asymptomatic cases, and concurrent illnesses requiring treatment with antibiotics effective against syphilis. 2. if RPR titers were found to be 1:4 or less or the T. pallidum particle agglutination test was nonreactive, participants were retrospectively excluded from the trial unless primary syphilis was confirmed by the finding of T. pallidum in ulcer exudates on direct immunofluorescence

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

Active Comparator

Arm Label

single dose benzathine penicillin G.

three doses of benzathine penicillin G.

Arm Description

single dose benzathine penicillin G.

three doses of benzathine penicillin G.

Outcomes

Primary Outcome Measures

Rapid plasma reagin titers

Secondary Outcome Measures

Full Information

NCT ID

NCT02857959

First Posted

August 3, 2016

Last Updated

November 15, 2018

Sponsor

Jun Li

1. Study Identification

Unique Protocol Identification Number

NCT02857959

Brief Title

One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

Official Title

Doctor of Medicine

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

June 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun Li

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to observe the serological response to 1 or 3 weekly doses of benzathine penicillin G in patients with early syphilis.

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

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single dose benzathine penicillin G.

Arm Type

Experimental

Arm Description

single dose benzathine penicillin G.

Arm Title

three doses of benzathine penicillin G.

Arm Type

Active Comparator

Arm Description

three doses of benzathine penicillin G.

Intervention Type

Drug

Intervention Name(s)

Benzathine Penicillin G

Primary Outcome Measure Information:

Title

Rapid plasma reagin titers

Time Frame

up to 9 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis A rapid plasma reagin (RPR) test was positive, with a titer were 1:4 or higher. In addition, Treponema pallidum particle agglutination assay and/or fluorescent treponemal antibody absorption test were reactive. Exclusion Criteria: 1.Patients who were pregnancy, known allergy to penicillin, use of antibiotics active against syphilis during the preceding six months for symptomatic cases or during the preceding two years for asymptomatic cases, and concurrent illnesses requiring treatment with antibiotics effective against syphilis. 2. if RPR titers were found to be 1:4 or less or the T. pallidum particle agglutination test was nonreactive, participants were retrospectively excluded from the trial unless primary syphilis was confirmed by the finding of T. pallidum in ulcer exudates on direct immunofluorescence -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Li, M.D.

Phone

86-010-69151504

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

lijun35@hotmail.com

12. IPD Sharing Statement

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One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

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