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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000033986 |
Receipt No. | 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 | 2020/02/19 |
Basic information | ||
Public title | Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial | |
Acronym | Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial | |
Scientific Title | Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial | |
Scientific Title:Acronym | Low dose amoxycillin versus amoxycillin and probenecid for syphilis in HIV patient: a randomised, open-label, non-inferiority trial | |
Region |
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Condition | ||||
Condition | Syphilis | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Investigate the efficacy and safety of low-dose amoxycillin versus amoxycillin and probenecid |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Treatment success rate at one year after treatment |
Key secondary outcomes | Treatment success rate at 3, 6, 9 months after treatment and adverse event rate |
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 | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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) |
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Interventions/Control_2 | 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) |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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 |
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Key exclusion criteria | 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 |
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Target sample size | 112 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Center for Global Health and Medicine Hospital | ||||||
Division name | AIDS Clinical Center | ||||||
Zip code | |||||||
Address | 1-21-1, Toyama, Shinjuku-ku,Tokyo 162-8655, Japan | ||||||
TEL | 03-3202-7181 | ||||||
dmizushi@acc.ncgm.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Center for Global Health and Medicine Hospital | ||||||
Division name | AIDS Clinical Center | ||||||
Zip code | |||||||
Address | 1-21-1, Toyama, Shinjuku-ku,Tokyo 162-8655, Japan | ||||||
TEL | 03-3202-7181 | ||||||
Homepage URL | |||||||
nandou@hosp.ncgm.go.jp |
Sponsor | |
Institute | self-finance |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 国立国際医療研究センター病院(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038744 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |