Skip to content

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02884115
Enrollment
150
Registered
2016-08-30
Start date
2016-08-31
Completion date
2020-09-30
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syphilis

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).

Interventions

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rapid plasma regain titer6 months after retreatment

Countries

China

Contacts

Primary ContactJun Li, M.D.
lijun35@hotmail.com86-010-69151504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026