UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Syphilis
Classification by specialty	Medicine in general Infectious disease Adult
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	Medicine
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)
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)
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) 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
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
Target sample size	112

Research contact person
Name of lead principal investigator	1st name Middle name Last name Daisuke Mizushima
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
Email	dmizushi@acc.ncgm.go.jp

Public contact
Name of contact person	1st name Middle name Last name Naokatsu Ando
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
Email	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
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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	2018 Year 09 Month 03 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	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 03 Day
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	2018 Year 09 Month 01 Day
Last modified on	2018 Year 09 Month 03 Day

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

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