Treatment Responses of Early Syphilis to Single-dose Ceftriaxone Plus Doxycycline Versus Single-dose Benzathine Penicillin G Plus Doxycycline in PLWH

202206138MIND

In a prospective study investigating the prevalence of STIs among at-risk PLWH, the prevalence of Chlamydia trachomatis and N. gonorrhoeae was 24.7% and 12.1%, respectively. Surprisingly, the study found high rates of C. trachomatis and/or N. gonorrhoeae co-infections in PLWH with recent hepatitis C virus (HCV) infection (50%), HBsAg positivity (44%), and early syphilis (36%). Considering the high rate of sexually transmitted co-infections, combination therapy of single-dose ceftriaxone plus 7-day doxycycline for early syphilis may provide convenience and benefit to treatment of N. gonorrhoeae and C. trachomatis co-infections at a single clinic encounter. In the present study, this study aim to compare the efficacy of ceftriaxone plus doxycycline versus BPG plus doxycycline as the treatment for early syphilis among PLWH.

2023-03-10

2025-03-15

2025-03-15

Recruiting

Early phase I

300

Inclusion Criteria: * PLWH aged 20 years or more * PLWH with early syphilis (i.e. primary, secondary, or early latent syphilis), confirmed by a positive rapid plasma reagin (RPR) titer with a reactive Treponema pallidum particle agglutination (TPPA) assay. * PLWH has provided informed consent Exclusion Criteria: * PLWH with RPR titers of less than 4 * Exposure to antibiotics with activity against T. pallidum, such as penicillins, third- generation cephems, doxycycline, or macrolides, within the preceding 4 weeks * A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum * A history of intolerance to penicillin, ceftriaxone, or doxycycline * Pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

2023-08-08