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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02884115
Collaborator
(none)
150
1
2
49
3.1

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
  • Drug: benzathine penicillin
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

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

  1. Rapid plasma regain titer [6 months after retreatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
Jun Li, M.D., Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT02884115
Other Study ID Numbers:
  • PUMCH-2016080
First Posted:
Aug 30, 2016
Last Update Posted:
Nov 16, 2018
Last Verified:
Nov 1, 2018

Study Results

No Results Posted as of Nov 16, 2018