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
Jun Li
M.D.
Peking Union Medical College Hospital
Study Sites (1)
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