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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004426
Receipt No. R000005279
Scientific Title Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies based on the PK-PD index
Date of disclosure of the study information 2010/10/22
Last modified on 2015/08/18

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Basic information
Public title Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies based on the PK-PD index
Acronym Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies
Scientific Title Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies based on the PK-PD index
Scientific Title:Acronym Clinical significance of arbekacin for MRSA infection in patients with hematological malignancies
Region
Japan

Condition
Condition Methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with hematological malignancies (including probable cases).
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clinical efficacy and safety of arbekacin for MRSA infection in patients with hematological malignancies will be investigated using the PK-PD index set at Cmax/MIC equal to or larger than 8.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy rating:
The clinical response will be rated as "effective" if the symptoms of infection have disappeared or significantly improved, taking into account the body temperature, heart rate, white blood cell count, etc. at baseline and after completion/discontinuation of the treatment.

Toxicity rating:
Adverse events caused by administration of arbekacin will be rated as followings.
i) Leading to death
ii) Life threatening
iii) Requiring hospitalization or prolongation of hospital stay
iv) Leading to ever lasting malfunction
v) Leading to congenital malformation or deficiency
vi) Any other adverse events considered clinically serious
vii) Any adverse event not applicable to i) - iv)
Key secondary outcomes 1)Effectiveness and clinical parameters; actual Cmax (or Cmax/MIC), probability of changing to other anti-MRSA drugs, CRP value before and after the treatment.

2)Factors influencing clinical outcome; evaluating patients' characteristics associated with effectiveness and toxicity.

3)Bacteriological response rating; actual isolate changes before and after the treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of antibiotic
Interventions/Control_2
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 Adult patients with hematological malignancies complicated with infection (including Febrile neutropenia) that is caused by or suspected of being caused by MRSA, who have given their consent to this study. However, administration will be discontinued whenever it is confirmed by the results of drug sensitivity testing that it is not sensitive to arbekacin.
Key exclusion criteria 1) Patients who have received any other anti-MRSA agents (vancomycin, teicoplanin, linezolid) within 2 weeks before administration of arbekacin.
2) Patients with reduced renal function (creatinine clearance, 30 mL/min/1.73 m2 or less).
3) Patients who are pregnant or might be pregnant.
4) Patients with a medical history or a family history of deafness induced by aminoglycoside antibiotics, or other patients with deafness.
5) Patients on any form of dialysis (hemodialysis: HD; continuous ambulatory peritoneal dialysis: CAPD; continuous hemodiafiltration, CHDF).
6) Patients deemed unsuitable for enrollment by the physician in charge for any other reason.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Miura
Organization Nihon University School of Medicine
Division name Division of Hematology & Rheumatology
Zip code
Address 30-1, Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Miura
Organization Nihon University School of Medicine
Division name Division of Hematology & Rheumatology
Zip code
Address 30-1, Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email javis@med.nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded
2015 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 21 Day
Last modified on
2015 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005279

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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