drugset / Trial / NCT02884115

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

NCT02884115

Phase 4 Unknown 150 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2016-08
Primary completion
2020-09
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzathine Penicillin Small molecule

Indications