UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Nagasaki evaluation organization for clinical interventions

Institute

Department

Personal name

Organization

Nagasaki evaluation organization for clinical interventions

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

07

Month

29

Day

Last modified on

2011

Year

07

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002763