Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Retreatment group Serofast early syphilis cases retreated with three doses benzathine penicillin |
Drug: benzathine penicillin
|
No Intervention: Control group Absence of any retreatment |
Outcome Measures
Primary Outcome Measures
- Rapid plasma regain titer [6 months after retreatment]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PUMCH-2016080