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

NCT ID: NCT02857959

Last Updated: 2018-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Syphilis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single dose benzathine penicillin G.

single dose benzathine penicillin G.

Group Type EXPERIMENTAL

Benzathine Penicillin G

Intervention Type DRUG

three doses of benzathine penicillin G.

three doses of benzathine penicillin G.

Group Type ACTIVE_COMPARATOR

Benzathine Penicillin G

Intervention Type DRUG

Interventions

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Benzathine Penicillin G

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jun Li

OTHER

Sponsor Role lead

Responsible Party

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Jun Li

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Li, M.D.

Role: CONTACT

86-010-69151504

Facility Contacts

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Jun Li, M.D.

Role: primary

86-010-69151504

Other Identifiers

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PUMCH-2016078

Identifier Type: -

Identifier Source: org_study_id

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