Early Syphilis
Conditions
Keywords
sexually transmitted infection, Treponema pallidum, gonorrhea, chlamydia
Brief summary
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.
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)
Interventions
DRUGDoxycycline
doxycycline (100 mg orally twice daily for 7 days)
DRUGCeftriaxone
Ceftriaxone (1g intramuscularly once)
benzathine penicillin G (2.4 MU intramuscularly once)
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Month 3 | Month 3 | Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive |
| Rate of Serologic Response at Month 12 | Month 12 | Serologic response is defined as either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORKuan-Yin Lin
National Taiwan University Hospital
Participant flow
Recruitment details
Recruitment started from March 10, 2023, to August 16, 2024. Participants were recruited from infectious diseases clinics at the National Taiwan University Hopsital, Taiwan.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39 years |
| CD4 count at baseline | 565 cells/mm^3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Receiving ART at baseline | 56 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 53 |
| other Total, other adverse events | 26 / 56 | 15 / 53 |
| serious Total, serious adverse events | 0 / 56 | 0 / 53 |
Outcome results
None listed