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

Syphilis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02884115
• Other study ID #: PUMCH-2016080
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: September 2020

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Jun Li, M.D.
• Phone: 86-010-69151504
• Email: lijun35[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Syphilis

Intervention

Drug:
• benzathine penicillin

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid plasma regain titer		6 months after retreatment