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

Amoxicillin study for early syphilis

Ando Naokatsu

National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan

nandou@hosp.ncgm.go.jp

Ando Naokatsu

National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan

+81-3-3202-7181

nandou@hosp.ncgm.go.jp

Recruiting

Feb. 18, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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

Both

Syphilis

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

Syphilis, Sexually transmitted infections, treponema pallidum

benzathine penicillin, amoxicillin, non-inferiority, superiority

D013587

D000073843

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

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

+81-3-3202-7181

Nov. 15, 2021

No

none