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

Jun Li

Status and phase: Unknown; Phase 4

Conditions: Syphilis

Treatments: Drug: Benzathine Penicillin G

Study type: Interventional

Funder types: Other

Identifiers

NCT02857959

PUMCH-2016078

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

single dose benzathine penicillin G.

Experimental group

Description:

single dose benzathine penicillin G.

Treatment:

Drug: Benzathine Penicillin G

three doses of benzathine penicillin G.

Active Comparator group

Description:

three doses of benzathine penicillin G.

Treatment:

Drug: Benzathine Penicillin G