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

NCT02857959 | Unknown Phase 4

• 1 other identifier: PUMCH-2016078
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (1)

• Rapid plasma reagin titers

  up to 9 months after treatment

Study Arms (2)

single dose benzathine penicillin G.

EXPERIMENTAL

single dose benzathine penicillin G.

Drug: Benzathine Penicillin G

three doses of benzathine penicillin G.

ACTIVE COMPARATOR

three doses of benzathine penicillin G.

Drug: Benzathine Penicillin G

Interventions

Benzathine Penicillin G DRUG

single dose benzathine penicillin G.; three doses of benzathine penicillin G.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jun Li: lead

Study Sites (1)

Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Beijing, China

RECRUITING

MeSH Terms

Conditions

Syphilis

Interventions

Penicillin G

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jun Li, M.D.

CONTACT

86-010-69151504; lijun35@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

CN (1)