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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003972
Receipt No. R000004789
Scientific Title A study on the utility of TAZ/PIPC in the treatment of nosocomial pneumonia - Comparison with MEPM -
Date of disclosure of the study information 2010/07/31
Last modified on 2015/09/29

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Basic information
Public title A study on the utility of TAZ/PIPC in the treatment of nosocomial pneumonia - Comparison with MEPM -
Acronym A study on the utility of TAZ/PIPC in the treatment of nosocomial pneumonia - Comparison with MEPM -
Scientific Title A study on the utility of TAZ/PIPC in the treatment of nosocomial pneumonia - Comparison with MEPM -
Scientific Title:Acronym A study on the utility of TAZ/PIPC in the treatment of nosocomial pneumonia - Comparison with MEPM -
Region
Japan

Condition
Condition Nosocomial pneumonia
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Orthopedics Urology Anesthesiology
Neurosurgery Cardiovascular surgery Plastic surgery
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of tazobactam/piperacillin (TAZ/PIPC), which has been recommended for the treatment of moderate or severer nosocomial pneumonia in the guidelines for treatment of adult nosocomial pneumonia presented by the Japanese Respiratory Society in June 2008, with those of a carbapenem antibiotic, meropenem.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical effect (efficacy ratio) at the end or discontinuation of administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TAZ/PIPC.
Enrollment period: 17 months and study period: 18 months.
Interventions/Control_2 MEPM.
Enrollment period: 17 months and study period: 18 months.
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 Patients with nosocomial pneumonia:
16-year old or older patients with pneumonia which appeared newly more than 48 hours after hospitalization (including aspiration pneumonia and ventilator-associated pneumonia)*
*[Diagnosis of nosocomial pneumonia]
Patients showing clinical symptoms such as coughing, expectoration, fever, etc., and a shadow of infiltration considered to appear newly in the imaging diagnosis such as thoracic X-ray or CT, etc.
Key exclusion criteria (1) Patients with a history of hypersensitivity to the ingredients of this product, such as shock
(2) Children (younger than 16 years old)
(3) Patients with infectious mononucleosis
(4) Patients receiving sodium valproate
(5) Pregnant women, lactating women, or patients possibly to be pregnant
(6) Patients with hepatic, renal or cardiac diseases, immunodeficiency, other serious underlying diseases or complications, who have difficulty in evaluation of the efficacy of this product.
(7) Patients in the group with severe disease (C group), for whom combination with antimicrobial agents is recommended in the guidelines for treatment of nosocomial pneumonia of the Japanese Respiratory Society
(8) Other patients judged to be unsuitable as subjects by the physicians in charge
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Yamagishi
Organization Aichi Medical University Hospital
Division name Department of Infection Control and Prevention
Zip code
Address 1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL 0561-62-3311
Email yymgs@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Yamagishi
Organization Aichi Medical University Hospital
Division name Department of Infection Control and Prevention
Zip code
Address 1-1 Yazakokarimata,Nagakute,Aichi,480-1195, Japan
TEL 0561-62-3311
Homepage URL
Email yymgs@aichi-med-u.ac.jp

Sponsor
Institute Department of Infection Control and Prevention, Aichi Medical University Hospital
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
2010 Year 07 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
2010 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 31 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004789

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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