Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin

Phase 4

• Conditions: Syphilis
• Interventions: Drug: benzathine penicillin

• Registration Number: NCT02884115
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-08-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment

Exclusion Criteria

• Human immunodeficiency virus (HIV)-infected
• Baseline serology showed a nonreactive RPR test
• follow-up is inadequate
• Allergic to penicillin
• Pregnant woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retreatment group	benzathine penicillin	Serofast early syphilis cases retreated with three doses benzathine penicillin

Primary Outcome Measures

Name	Time	Method
Rapid plasma regain titer	6 months after retreatment

Trial Locations

Locations (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