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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 2018/09/03

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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
Email

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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