UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008226 |
|---|---|
| Receipt number | R000009623 |
| Scientific Title | An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study - |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2015/04/23 12:20:27 |
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Basic information
Public title
An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -
Acronym
An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -
Scientific Title
An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -
Scientific Title:Acronym
An evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection - A multicenter, unblinded clinical study -
Region
| Japan |
Condition
Condition
multidrug-resistant Gram-negative bacterial infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of colistimethate sodium injection in patients with multidrug-resistant Gram-negative bacterial infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical response at the end of administration.
Key secondary outcomes
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
Colistin is given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg (7,500 to 15,000 IU/kg as colistimethate sodium) per day. Daily dose is reduced depending on the severity of renal impairment of the subject. Dosing period is 14 days and administration can be ended when symptom is improved.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient infected with Gram-negative bacteria;
- resistant to 3 types of antibiotics (carbapenem, fluoroquinolone and aminoglycoside),
- or treatment of those antibiotics is ineffective,
- or treatment of those antibiotics is expected to be ineffective.
Patient aged 16 years old or older.
Key exclusion criteria
Allergy for polymyxin.
Woman who is pregnant or has chance to be pregnant or breast-feeding.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Sunakawa |
Organization
The Kitasato Institute
Division name
Kitasato University Research Organization for Infection Control Science
Zip code
Address
5-9-1 Shirokane, Minato-Ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Kitasato Institute
Division name
Kitasato University Research Organization for Infection Control Science
Zip code
Address
5-9-1 Shirokane, Minato-Ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
The clinical study group for MDRN
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Infectious Disease and Infection Control, Jikei University School of Medicine
Department of Microbiology and Infectious Diseases, Toho University Faculty of Medicine
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
| 2012 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 12 | 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
| 2012 | Year | 06 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
