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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032006
Receipt No. R000036524
Scientific Title An open-label randomized controlled trial of ampicillin/cloxacillin and ceftriaxone for empirical treatment of infective endocarditis
Date of disclosure of the study information 2018/03/31
Last modified on 2019/03/03

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Basic information
Public title An open-label randomized controlled trial of ampicillin/cloxacillin and ceftriaxone for empirical treatment of infective endocarditis
Acronym Comparative trial of ampicillin/cloxacillin with ceftriaxone for empirical treatment of infective endocarditis
Scientific Title An open-label randomized controlled trial of ampicillin/cloxacillin and ceftriaxone for empirical treatment of infective endocarditis
Scientific Title:Acronym Comparative trial of ampicillin/cloxacillin with ceftriaxone for empirical treatment of infective endocarditis
Region
Japan

Condition
Condition Infective endocarditis
Classification by specialty
Medicine in general Cardiology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recommendations of antimicrobials for empirical treatment of infective endocarditis are different in each guideline. In Japanese guideline, ampicillin/sulbactam or ceftriaxone are recommended for empirical treatment, whereas in European guideline, ampicillin/cloxacillin is recommended for empirical treatment. So, the aim of this study is to compare the ampicillin/cloxacillin-based regimen with ceftriaxone-based regimen as the empirical treatment of infective endocarditis for their efficacy, outcome and adverse events.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Outcome of infective endocarditis at the end of antimicrobial treatment
Key secondary outcomes Days for defervescence less than 37 degrees Celsius, days of hospitalization, outcome at discharge, necessity of surgery during hospitalization, outcome of infective endocarditis 3 months after the end of antimicrobial treatment
Adverse events on skin, blood, liver and kidney

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention: Ampicillin/cloxacillin 4 g q4h div maximum for 6 weeks + gentamicin 3 mg/kg q24h div maximum for 2 weeks
Interventions/Control_2 Control: Ceftriaxone 2 g q24h div maximum for 6 weeks
+ gentamicin 3 mg/kg q24h div maximum for 2 weeks
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 Patients with confirmed or suspected diagnosis of infective endocarditis based on the modified Duke's criteria, who need to start empirical treatment waiting for the result of blood cultures.
Key exclusion criteria Causative microorganism already confirmed, history of allergy or contraindication of penicillin, cepharosporins and aminoglycosides, history of prosthetic valve replacement within 1 year, eGFR less than 50 mL/min, WBC less than 1,000/microL, when physicians in charge chose another treatment regimens
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Naito
Organization Juntendo University Faculty of Medicine
Division name Department of General Medicine
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
TEL 03-3813-3111
Email naito@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Uehara
Organization Juntendo University Faculty of Medicine
Division name Department of General Medicine
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email yuuehara@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 31 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 03 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 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 03 Month 30 Day
Last modified on
2019 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036524

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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