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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Syphilis

Treatments: Drug: benzathine penicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT02884115

PUMCH-2016080

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Retreatment group

Active Comparator group

Description:

Serofast early syphilis cases retreated with three doses benzathine penicillin

Treatment:

Drug: benzathine penicillin

Control group

No Intervention group

Description:

Absence of any retreatment