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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011835
Receipt No. R000013806
Scientific Title Efficacy and safety of meropenem (3g/day) in the treatment of severe/refractory respiratory infections
Date of disclosure of the study information 2013/10/31
Last modified on 2015/02/10

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Basic information
Public title Efficacy and safety of meropenem (3g/day) in the treatment of severe/refractory respiratory infections
Acronym Efficacy and safety of meropenem (3g/day) in the treatment of severe/refractory respiratory infections
Scientific Title Efficacy and safety of meropenem (3g/day) in the treatment of severe/refractory respiratory infections
Scientific Title:Acronym Efficacy and safety of meropenem (3g/day) in the treatment of severe/refractory respiratory infections
Region
Japan

Condition
Condition severe/refractory respiratory infections
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of meropenem (3g/day) in the treatment in patients with severe/refractory respiratory infections.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical efficacy at the end of meropenem (3g/day) 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 Meropenem (3g/day) is given intravenously
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 1.Patients 20 years of age and older
2.Patients with severe/very severe pneumonia according to the Japan Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia in Adults.
3.Patients with respiratory infections other than community-acquired pneumonia or hospital-acquired pneumonia with systemic inflammatory response syndrome (SIRS)
Key exclusion criteria 1.Patients who had been treated with meropenem
2.Contraindication for meropenem
3.Liver insufficiency (elevated levels of AST/ALT more than 5 times of the upper limits)
4.Renal insufficiency (elevated levels of BUN/creatinine more than 2 times of the upper limits)
5.Patients anticipating being susceptive of convulsion after brain disorders
6.Patients deemed ineligible by the attending physicians for various reasons.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Kawanami
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL 093-603-1611
Email namihei@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori Kawanami
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email namihei@med.uoeh-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2013 Year 10 Month 31 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
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 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
2013 Year 09 Month 23 Day
Last modified on
2015 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013806

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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