UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032006 |
|---|---|
| Receipt number | 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 | 2020/10/02 13:42:18 |
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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
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
yuuehara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 18 | Day |
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
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036524
