UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003972 |
|---|---|
| Receipt number | 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 13:59:29 |
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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 |
| Obstetrics 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
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
yymgs@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Infection Control and Prevention, Aichi Medical University Hospital
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004789
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