Early Syphilis, Latent, Serological Relapse After Treatment
Conditions
Keywords
syphilis, rapid plasma reagin
Brief summary
This randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin G (BPG) (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose BPG. The primary outcome is serologic response, defined as a decline of rapid plasma reagin (RPR) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (STIs) assessed by nucleic-acid amplification test (NAAT) at week 4.
Interventions
Benzathine Penicillin G (2.4 MU intramuscularly once)
doxycycline (100 mg orally twice daily for 7 days)
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Far Eastern Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Taoyuan General Hospital
National Cheng-Kung University Hospital
Chi Mei Medical Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* People living with HIV (PLWH) aged ≥18 years with early syphilis * Confirmed by a positive RPR titer with a reactive TPPA assay
Exclusion criteria
* PWH with RPR titers of \<4 * Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides) * A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum (penicillin, 3rd cephalosporin, doxycycline, macrolides) * Testing positive for C. trachomatis and M. genitalium, for which doxycycline or macrolide was administered * A history of intolerance to penicillin or doxycycline * PLWH have already participated in this study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serologic response | Weeks 24 and week 48 | Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiologic response of syphilis | Week 4 | T. pallidum PCR Ct value \>38 |
| Microbiologic response of bacterial STIs | Week 4 | negative STI PCR results |
| Safety of study treatment | Week 4 | — |
| Adherence evaluation of tablet intake | Week 4 | — |
Countries
Taiwan
Contacts
Primary ContactKuan-Yin Lin, MD
Outcome results
None listed