UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046856 |
|---|---|
| Receipt number | R000053445 |
| Scientific Title | Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label,randomized, controlled clinical trial |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2025/02/09 09:58:38 |
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Basic information
Public title
Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label,randomized, controlled clinical trial
Acronym
Amoxicillin study for early syphilis
Scientific Title
Efficacy of amoxicillin therapy versus benzathine penicillin G for early syphilis, a multicenter, open-Label,randomized, controlled clinical trial
Scientific Title:Acronym
Amoxicillin study for early syphilis
Region
| Japan |
Condition
Condition
Early syphilis
Classification by specialty
| Medicine in general | Infectious disease | Obstetrics and Gynecology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy and safety of amoxycillin and probenecid compared with penicillin G benzathine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug A:BPG intramuscular injection of 2.4 million units
Interventions/Control_2
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 day for 14 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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
Target sample size
208
Research contact person
Name of lead principal investigator
| 1st name | Naokatsu |
| Middle name | |
| Last name | Ando |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
1628655
Address
1-21-1 Toyama
TEL
0332027181
nandou@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Naokatsu |
| Middle name | |
| Last name | Ando |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
1628655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
http://www.acc.ncgm.go.jp/general/ResearchAnnounce.html
nandou@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Management, Management and Planning Bureau National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-ku, Tokyo, Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人国立国際医療研究センター、パーソナルヘルスクリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053445
