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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Syphilis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Retreatment group

Serofast early syphilis cases retreated with three doses benzathine penicillin

Group Type ACTIVE_COMPARATOR

benzathine penicillin

Intervention Type DRUG

Control group

Absence of any retreatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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benzathine penicillin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No