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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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