- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02884115
Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin
November 15, 2018 updated by: Jun Li, Peking Union Medical College Hospital
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
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Recruiting
- Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Retreatment group
Serofast early syphilis cases retreated with three doses benzathine penicillin
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|
NO_INTERVENTION: Control group
Absence of any retreatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rapid plasma regain titer
Time Frame: 6 months after retreatment
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6 months after retreatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
August 22, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (ESTIMATE)
August 30, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 16, 2018
Last Update Submitted That Met QC Criteria
November 15, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sexually Transmitted Diseases, Bacterial
- Spirochaetales Infections
- Treponemal Infections
- Syphilis
- Anti-Infective Agents
- Anti-Bacterial Agents
- Penicillins
- Penicillin G Benzathine
- Penicillin G
- Penicillin G Procaine
Other Study ID Numbers
- PUMCH-2016080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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