UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002122
Receipt No. R000002584
Scientific Title An exploratory study of administration of colistin for multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Date of disclosure of the study information 2009/06/26
Last modified on 2016/02/29

* 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 An exploratory study of administration of colistin for multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Acronym An exploratory study of administration of colistin for multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Scientific Title An exploratory study of administration of colistin for multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Scientific Title:Acronym An exploratory study of administration of colistin for multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Region
Japan

Condition
Condition multidrug-resistant Pseudomonas aeruginosa infections in patients with hematological disease.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of colistin as therapy for the multidrug resistance Pseudomonas aeruginosa infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A clinical response at the end of colistin therapy
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 administered intravenously. The dosage is 1.25-2.5mg/kg twice a day. The treetment period is between 3 and 28 days.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients with hematological disease. (Patients who received hematopoietic stem cell transplantation for non-hematological disease are included)
2 Multidrug-resistant Pseudomonas aeruginosa was detected by bacteria culture within one month
3 Patients with symptons due to Multidrug-resistant Pseudomonas aeruginosa infection
4 The patients who recieved intraveous antibiotic for more than three days within one week and the symptons of infection did not improve.
Key exclusion criteria 1. Allergy for colistin
2. A woman who is pregnant or has chance to be pregnant.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumihiko Nakamura
Organization University of Tokyo Hospital
Division name hematology and Oncology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email fnakamur-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiko Nakamura
Organization University of Tokyo Hospital
Division name Hematology and Oncology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email fnakamur-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital
Department of Hamatology and Oncology
Institute
Department

Funding Source
Organization None
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
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
2009 Year 06 Month 26 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
2009 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 25 Day
Last modified on
2016 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.