UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006538 |
|---|---|
| Receipt number | R000007717 |
| Scientific Title | Efficacy of using antimicrobials based on PK/PD principle in the treatment of NHCAP |
| Date of disclosure of the study information | 2011/10/14 |
| Last modified on | 2012/11/19 10:41:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Acronym
Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Scientific Title
Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Scientific Title:Acronym
Efficacy of using antimicrobials based on PK/PD principle in the treatment of
NHCAP
Region
| Japan |
Condition
Condition
NHCAP(HCAP)
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of using antimicrobials based on PK/PD in NHCAP patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of hospitalization
Key secondary outcomes
Mortality in hospital
Clinical effect, days 4 and 7
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:using SBT/ABPC 1.5g q6hr
Interventions/Control_2
Group B:using SBT/ABPC 3.0g q12hr
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthcare associated pneumonia (HCAP)
Patients who satisfy the criteria at least one item of each of A,B and C
A:1 fever(BT>37.0)
2 cough
3 hypoxemia
B:
1 Increased white blood cell count (WBC>10000/mm3), stab cells>15%, or decreased white blood cell count (WBC<4500/mm3)
2 Positive CRP
3 X-ray examination or CT scan of the chest reveal new infiltrative shadows
C:Patients who were admitted to nursing homes, care/rehabilitation facilities or health/care facilities for recuperation (for more than 48 hours) ,or who were hospitalized for more than two days for the past 90 days
Key exclusion criteria
1 Patients with renal dysfunction ( Ccr<10ml/min )
2 Immunocompromised patients or patients receiving immunosuppressive agents
3 Patients whose pneumonia could not be treated by SBT/ABPC
4 Patients with hypersensitivity to SBT/ABPC
5 Patients who were not considered as participant by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishio Kazumi |
Organization
Kawasaki Municipal Ida Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-27-1,ida,Nakahara,Kawasaki,210-0035,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Municipal Ida Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
83idasyo@city.kawasaki.jp
Sponsor or person
Institute
Kawasaki Municipal Ida Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Municipal Ida Hospital
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
| 2011 | Year | 10 | Month | 14 | 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 | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 10 | Month | 13 | Day |
Last modified on
| 2012 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
