Skip to main content
Clinical Trials/NCT02857959
NCT02857959UnknownPhase 4

Doctor of Medicine

Jun Li1 site in 1 country150 target enrollmentStarted: August 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Rapid plasma reagin titers

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • 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

Arms & Interventions

single dose benzathine penicillin G.

Experimental

single dose benzathine penicillin G.

Intervention: Benzathine Penicillin G (Drug)

three doses of benzathine penicillin G.

Active Comparator

three doses of benzathine penicillin G.

Intervention: Benzathine Penicillin G (Drug)

Outcomes

Primary Outcomes

Rapid plasma reagin titers

Time Frame: up to 9 months after treatment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jun Li
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jun Li

M.D.

Peking Union Medical College Hospital

Study Sites (1)

Loading locations...

Similar Trials