UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004426 |
|---|---|
| Receipt number | 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 17:54:26 |
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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
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
javis@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005279
