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Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline
Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline

NCT05980871

TerminatedPhase 4

Sponsor: National Taiwan University Hospital

Conditions: Early Syphilis

Interventions: Doxycycline, Ceftriaxone, benzathine penicillin G

Countries: Taiwan

In a prospective study investigating the prevalence of sexually transmitted infections (STIs) among at-risk people living with HIV (PLWH), the prevalence of Chlamydia trachomatis and Neisseria 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 benzathine penicillin G (BPG) plus doxycycline as the treatment for early syphilis among PLWH.

Eligibility overview

Sex: ALL

Age: 20 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Taipei, Taiwan, Taiwan