Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label,randomized, controlled clinical trial

Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label,randomized, controlled clinical trial - Amoxicillin study for early syphilis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046856

Enrollment

208

Registered

2022-02-10

Start date

2022-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early syphilis

Interventions

Drug A:BPG intramuscular injection of 2.4 million units Drug B: Amoxycillin and probenecid Oral: Amoxycillin at a dose of 1,500 mg twice a day for 14 days plus probenecid at a dose of 250 mg twice a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 20 years or older. 2. Patients provided an informed consent in writing. 3. Patients diagnosed with early syphilis based on the following criteria (i) positive RPR conversion or (ii) four-fold increase in RPR titer compared to previous RPR titer 4. Patients has a positive non-treponemal assay result.

Exclusion criteria

Exclusion criteria: 1. Individuals with pregnancy 2. Individuals with a history of known hypersensitivity to BPG, amoxicillin or probenecid. 3. Individuals with neurosyphilis including ocular syphilis and otosyphilis. 4. Individuals with late syphilis. 5. Patients required antibiotics that effective for syphilis within the preceding three weeks 6. Person who are judged by their physicians in charge to be ineligible for any reason

Design outcomes

Primary

Measure	Time frame
Serological cure rate at 6 months after treatment a four-fold decrease in titer in the non-treponemal assay (RPR) at month 6 or a subsequent negative result in the non-treponemal test	—

Secondary

Measure	Time frame
1. Serological cure rate at 3, 9, and 12 months after treatment 2. Jarisch-Herxheimer reactions (systemic symptoms such as fever, skin rash extension, and myalgia within 2 days of treatment) 3. Allergic reactions (new systemic symptoms such as fever and skin rash that appeared after 4 days) 4. Medication adherence rate 5. Serological cure rate summerized by HIV status (at 6 months and 12 months) 6. Time to serological cure summerized by RPR methods 7. Composite endpoint (endpoint serological cure,incidence of adverse drug reaction) evaluated by DOOR methods	—

Measure

Time frame

1. Serological cure rate at 3, 9, and 12 months after treatment 2. Jarisch-Herxheimer reactions (systemic symptoms such as fever, skin rash extension, and myalgia within 2 days of treatment) 3. Allergic reactions (new systemic symptoms such as fever and skin rash that appeared after 4 days) 4. Medication adherence rate 5. Serological cure rate summerized by HIV status (at 6 months and 12 months) 6. Time to serological cure summerized by RPR methods 7. Composite endpoint (endpoint serological cure,incidence of adverse drug reaction) evaluated by DOOR methods

—

Countries

Japan

Contacts

Public ContactNaokatsu Ando

National Center for Global Health and Medicine AIDS Clinical Center

nandou@hosp.ncgm.go.jp0332027181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026