Unique ID issued by UMIN | UMIN000033986 |
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Receipt number | R000038744 |
Scientific Title | Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2023/11/20 13:48:54 |
Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial
Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial
Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial
Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial
Japan |
Syphilis
Medicine in general | Infectious disease | Adult |
Others
NO
Investigate the efficacy and safety of low-dose amoxycillin versus amoxycillin and probenecid
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Treatment success rate at one year after treatment
Treatment success rate at 3, 6, 9 months after treatment and adverse event rate
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
amoxycillin 500 mg orally three times a day
14 days for early syphilis(primary, secondary and early latent syphilis)
28 days for late syphilis(late latent syphilis and unknown duration of syphilis)
amoxycillin 1,000 mg orally three times a day and probenecid 250 mg orally three times a day
14 days for early syphilis(primary, secondary and early latent syphilis)
28 days for late syphilis(late latent syphilis and unknown duration of syphilis)
20 | years-old | <= |
Not applicable |
Male and Female
1) HIV patient
2) The diagnosis of syphilis was based on a) or b)
a) Serum rapid plasma regain(RPR) titers is 8 or greater and positive Treponema. Pallidum Hemagglutination(TPHA) result. When serum RPR titers is 8, the diagnosis of syphilis requires signs of syphilis like chancre or skin rash.
b) 4-fold or more rise in RPR titer from the individual's prior test
1) pregnant or breast feeding woman
2) a history of amoxycillin or probenecid allergy
3) otosyphilis, ocular syphilis or neurosyphilis diagnosed based on the findings of cerebrospinal fluid
4) patient who needs antibiotics other than the antibiotics we used in this study which is effective for syphilis at diagnosis
5)patient who started antibiotics within 3 weeks before diagnosis
112
1st name | Daisuke |
Middle name | |
Last name | Mizushima |
National Center for Global Health and Medicine Hospital
AIDS Clinical Center
1628655
1-21-1, Toyama, Shinjuku-ku,Tokyo 162-8655, Japan
03-3202-7181
dmizushi@acc.ncgm.go.jp
1st name | Naokatsu |
Middle name | |
Last name | Ando |
National Center for Global Health and Medicine Hospital
AIDS Clinical Center
1628655
1-21-1, Toyama, Shinjuku-ku,Tokyo 162-8655, Japan
03-3202-7181
nandou@hosp.ncgm.go.jp
self-finance
None
Other
Certified Review Board of National Center for Global Health and Medicine
1-21-1 Toyama
03-3202-7181
rinrijm@hosp.ncgm.go.jp
NO
国立国際医療研究センター病院(東京都)
2018 | Year | 09 | Month | 03 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038744
Published
https://academic.oup.com/cid/article/77/5/779/7157181
112
A total of 112 participants were randomized into 2 groups. Serological cure rates within 12 months were 90.6% and 94.4% with the low-dose amoxicillin and combination regimens, respectively. Serological cure rates for early syphilis within 12 months were 93.5% and 97.9% with the low-dose amoxicillin and combination regimens, respectively. Non-inferiority of low-dose amoxicillin compared with amoxicillin plus probenecid overall and for early syphilis was not confirmed.
2023 | Year | 11 | Month | 20 | Day |
2023 | Year | 05 | Month | 09 | Day |
The baseline characteristics of the study participants were balanced between the groups. Regarding the syphilis stage, the proportion of participants with early syphilis was 86.6 percent, whereas that with late syphilis was 13.4 percent. At diagnosis, the median manual RPR titer was 64 (IQR 32-128), whereas the median automated RPR titer was 151.9 (IQR 58.8-345). Regarding HIV status, 91.1% of participants with HIV were on antiretroviral therapy, their median CD4 count was 525, and 94.6% of the PWH were virally suppressed.
Eligible participants were randomized in a one-to-one ratio to the combination of amoxicillin plus probenecid group or the low-dose amoxicillin group using a computer-generated random list. The block size of the randomization was four. The allocation was disclosed to the physician and patients. The laboratory technicians were unaware of participants' treatment allocations. Those assigned to the amoxicillin plus probenecid group received amoxicillin 1000 mg and probenecid 250 mg thrice daily, orally for 14 days for early and 28 days for late syphilis.
Alternatively, those assigned to the low-dose amoxicillin group received amoxicillin 500 mg thrice daily, orally for 14 days for early and 28 days for late syphilis.
In total, 21.4% of drug-related side effects were reported by study participants. Of those, 17.9% were reported for the low-dose regimen and 25.0% for the combination regimen. JH reactions occurred in 12.5% and 14.3% of participants on the low-dose and combination regimens, respectively. Drug rashes, nausea, and diarrhea occurred in 5.4%, 3.6%, and 0% of those on the low-dose regimen and 7.1%, 1.8%, and 5.4% of participants on the combination regimen, respectively. There were no significant differences between the groups for any of these safety variables. Based on the self-reported adherence, 93.8% of participants took more than 95% of the study drug.
The primary outcome was the cumulative serological cure rate within 12 months after treatment determined with the conventional RPR card test. A serological cure was a 4-fold decrease or negative conversion in RPR titer. Secondary outcomes were serological cure rates within 3, 6, and 9 months after treatment using the conventional or automated RPR test and serological cure rates within 12 months after treatment using the automated RPR test. Safety was assessed via self-reported side effects. Participants were asked at the second visit after completing their regimen about drug-related side effects, such as diarrhea, nausea, vomiting, and drug allergy was defined as new systemic reactions such as fever and skin rash that appeared after 4 days of treatment initiation. They were also asked about JarischHerxheimer (JH) reactions, defined as systemic reactions such as fever, rashes, or myalgia within 2 days of starting treatment, except for anaphylactic reactions. Adherence to the study drugs was assessed through self-reporting.
The data supporting this article are available on reasonable request from the corresponding author.
The data supporting this article are available on reasonable request from the corresponding author.
Completed
2018 | Year | 08 | Month | 13 | Day |
2018 | Year | 08 | Month | 13 | Day |
2018 | Year | 09 | Month | 03 | Day |
2022 | Year | 02 | Month | 03 | Day |
2022 | Year | 02 | Month | 03 | Day |
2022 | Year | 03 | Month | 03 | Day |
2022 | Year | 04 | Month | 03 | Day |
2018 | Year | 09 | Month | 01 | Day |
2023 | Year | 11 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038744
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