Treatment Responses of Early Syphilis to Ceftriaxone Plus Doxycycline
- Conditions
- Early Syphilis
- Interventions
- Registration Number
- NCT05980871
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
- Detailed Description
Enrolled criteria:
1. PLWH aged 20 years or more
2. 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.
3. PLWH has provided informed consent \*A participant with repeated syphilis can be repeated enrolled after signing an informed consent if the previous episode of early syphilis was successfully treated with achieving at least a 4-fold decrease in RPR titers and 48-week follow-up is completed.
Exclusion criteria:
1. PLWH with RPR titers of less than 4
2. Exposure to antibiotics with activity against T. pallidum, such as penicillins, third-generation cephems, doxycycline, or macrolides, within the preceding 4 weeks
3. A known or suspected infection other than syphilis requiring additional treatment with an antimicrobial active against T. pallidum
4. A history of intolerance to penicillin, ceftriaxone, or doxycycline
5. Pregnancy
Primary outcome:
Serologic response at month 6 (defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive)
Secondary outcomes:
1. Microbiologic response of syphilis (defined as T. pallidum PCR Ct value \>38) at week 4
2. Microbiologic response of bacterial STIs (defined as negative PCR results) at week 4
3. Serologic response at months 3 and 12
4. Safety of study treatment recorded by using a diary (all adverse events will be coded and graded according to Common Terminology Criteria for Adverse Events \[CTCAE\] v4.0.)
5. Adherence evaluation (the noting of tablet intake in the diary for the 7 days of the treatment period)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single-dose ceftriaxone plus doxycycline Ceftriaxone single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) single-dose BPG plus doxycycline benzathine penicillin G single-dose BPG (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) single-dose ceftriaxone plus doxycycline Doxycycline single-dose ceftriaxone (1g intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) single-dose BPG plus doxycycline Doxycycline single-dose BPG (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days)
- Primary Outcome Measures
Name Time Method Rate of serologic response at month 6 Month 6 Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
- Secondary Outcome Measures
Name Time Method Rate of microbiologic response of syphilis at week 4 Week 4 Microbiologic response of syphilis is defined as T. pallidum PCR Ct value \>38
Rate of microbiologic response of bacterial STIs at week 4 Week 4 Microbiologic response of bacterial STIs is defined as negative PCR results
Rate of serologic response at months 3 and 12 Months 3 and 12 Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
Trial Locations
- Locations (1)
Kuan-Yin Lin
🇨🇳Taipei, Taiwan