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NCT02857959 Clinical Trial

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

Syphilis Clinical Trial

Official title:
Doctor of Medicine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02857959
Other study ID # PUMCH-2016078
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 2016
Est. completion date August 2020

Study information
Verified date November 2018
Source Peking Union Medical College Hospital
Contact Jun Li, M.D.
Phone 86-010-69151504
Email lijun35@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date August 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Benzathine Penicillin G

Locations
Country Name City State
China Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China Beijing

Sponsors (1)
Lead Sponsor Collaborator
Jun Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rapid plasma reagin titers up to 9 months after treatment
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