Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin
Randomized, Clinical Trial to Compare the Serological Response Rates of Serofast Early Syphilis Cases Retreated With Three Doses Benzathine Penicillin and Absence of Any Retreatment
1 other identifier
interventional
150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 16, 2018
November 1, 2018
4.1 years
August 22, 2016
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rapid plasma regain titer
6 months after retreatment
Study Arms (2)
Retreatment group
ACTIVE COMPARATORSerofast early syphilis cases retreated with three doses benzathine penicillin
Control group
NO INTERVENTIONAbsence of any retreatment
Interventions
Eligibility Criteria
You may qualify if:
- Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment
You may not qualify if:
- Human immunodeficiency virus (HIV)-infected
- Baseline serology showed a nonreactive RPR test
- follow-up is inadequate
- Allergic to penicillin
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 30, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
November 16, 2018
Record last verified: 2018-11