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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02857959
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : November 16, 2018
Information provided by (Responsible Party):
Jun Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Syphilis Drug: Benzathine Penicillin G Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doctor of Medicine
Study Start Date : August 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: single dose benzathine penicillin G.
single dose benzathine penicillin G.
Drug: Benzathine Penicillin G
Active Comparator: three doses of benzathine penicillin G.
three doses of benzathine penicillin G.
Drug: Benzathine Penicillin G

Primary Outcome Measures :
  1. Rapid plasma reagin titers [ Time Frame: up to 9 months after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02857959

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Contact: Jun Li, M.D. 86-010-69151504

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Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China Recruiting
Beijing, China
Contact: Jun Li, M.D.    86-010-69151504   
Sponsors and Collaborators
Jun Li

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Responsible Party: Jun Li, M.D., Peking Union Medical College Hospital Identifier: NCT02857959    
Other Study ID Numbers: PUMCH-2016078
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents