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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002269
Receipt No. R000002763
Scientific Title Comparative Study of Usefulness of TAZ/PIPC and MEPM in Healthcare Associated Pneumonia (HCAP): Survey on the Actual Condition of Healthcare Associated Pneumonia (HCAP) in Japan
Date of disclosure of the study information 2009/08/01
Last modified on 2011/07/22

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Basic information
Public title Comparative Study of Usefulness of TAZ/PIPC and MEPM in Healthcare Associated Pneumonia (HCAP): Survey on the Actual Condition of Healthcare Associated Pneumonia (HCAP) in Japan
Acronym Comparative Study of Usefulness of TAZ/PIPC and MEPM in HCAP
Scientific Title Comparative Study of Usefulness of TAZ/PIPC and MEPM in Healthcare Associated Pneumonia (HCAP): Survey on the Actual Condition of Healthcare Associated Pneumonia (HCAP) in Japan
Scientific Title:Acronym Comparative Study of Usefulness of TAZ/PIPC and MEPM in HCAP
Region
Japan

Condition
Condition Healthcare associated pneumonia (HCAP) with a pneumonia severity index (PSI) score in risk class III or IV
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Actual condition in Japan of healthcare associated pneumonia (HCAP) specified in ATS/IDSA Guidelines is to be studied. Tazobactam-piperacillin hydrate (TAZ/PIPC) injection and meropenem hydrate (MEPM) injection are to be used in the cases of healthcare associated pneumonia with a pneumonia severity index (PSI) score in risk class III or IV to be compared with one another with respect to efficacy and safety. The courses of treatment with antimicrobials in HCAP cases are also to be evaluated (at the time of completion of administration and seven days after completion of administration).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Judgment of cure
A case judged as effective in the evaluation of clinical efficacy at the completion of administration and with no recurrence/flare-up seven days after completion of administration is judged as cured.
Key secondary outcomes Judgment of clinical efficacy
A case in which the symptoms/findings of pneumonia disappear or are improved and shadows in the lungs or inflammatory findings disappear or are improved is judged as effective.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of antibiotic (TAZ/PIPC)
Interventions/Control_2 Administration of antibiotic (MEPM)
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 Patients who satisfy the criteria (1) and at least one item of each of (2) and (3).
(1) Healthcare associated pneumonia (HCAP)
X-ray examination and CT scan of the chest reveal new infiltrative shadows, and one of the following conditions is satisfied.
*Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours)
*Patients who were hospitalized for more than two days for the past 90 days
*Patients who receive home fluid therapy
*Patients who receive treatment for wounds at home
(2) Fever, increased white blood cell count, positive CRP
*Fever:37 degrees Celsius and over (axillary temperature)
*Increased white blood cell count (WBC>10000/mm3), stab cells>15%, or decreased white blood cell count (WBC<4500/mm3)
*Positive CRP
(3) Findings of clinical symptoms
*Cough
*Expectoration of new purulent sputum or secretion from the airways. Aggravation of characteristics of sputum.
*Abnormal findings on auscultation and percussion (moist rale, dullness on percussion, decreased breath sounds)
*Aggravation of one of the followings: dyspnea, tachypnea, increase in respiratory rate (>30 breaths /min)
*Hypoxemia
Key exclusion criteria *Patients with bronchial obstruction or the history of obstructive pneumonia. The patients with COPD, however, are not excluded.
*Patients who can not tolerate the administration of selected drug three times a day.
*Patients placed on chronic maintenance dialysis
*Patients with serious hepatic dysfunction and renal dysfunction(CCr 30 ml/min or under ; -See the separate list of Scr.)
*Patients who have difficulty in judgment of the efficacy of selected drug (including patients suffering from cancer or other underlying diseases which prevent the evaluation).
*Patients infected probably with MRSA
*Patients who are given corticosteroid (prednisolone more than 10 mg/day)
*Patients with the history of hypersensitivity to the ingredients of selected drug, penicillin antimicrobials or carbapenem antimicrobials
*Pregnant or breastfeeding patients, or patients who have the possibility of being pregnant
*Patients with infectious mononucleosis
*Patients who were judged as ineligible by their treating physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno
Organization Nagasaki University Hospital
Division name Director
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yamamoto
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Homepage URL
Email yamamoto-ngs@umin.ac.jp

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

Funding Source
Organization Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 08 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
2009 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 29 Day
Last modified on
2011 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002763

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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