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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02884115
Other study ID # PUMCH-2016080
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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