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

Phase 4

• Conditions: Syphilis
• Interventions: Drug: Benzathine Penicillin G

• Registration Number: NCT02857959
• Lead Sponsor: Jun Li

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16
• Primary Completion: 2020-06
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single dose benzathine penicillin G.	Benzathine Penicillin G	single dose benzathine penicillin G.
three doses of benzathine penicillin G.	Benzathine Penicillin G	three doses of benzathine penicillin G.

Primary Outcome Measures

Name	Time	Method
Rapid plasma reagin titers	up to 9 months after treatment

Trial Locations

Locations (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