Amoxicillin study for early syphilis

JRCT ID: jRCT1031210615

Registered date:18/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Syphilis
• Date of first enrollment: 18/02/2022
• Target sample size: 208
• Study type: Interventional

Intervention(s)

Drug:BPG
Injection: intramuscular injection of BPG 2.4 million units

Drug: 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 day for 14 days

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ando Naokatsu
• Source(s) of Monetary Support: National Center for Global Health and Medicine
• Secondary ID(s): UMIN000046856