UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010972 |
|---|---|
| Receipt number | R000012841 |
| Scientific Title | A validation study of algorithm for treatment of nursing-healthcare associated pneumonia |
| Date of disclosure of the study information | 2013/06/15 |
| Last modified on | 2014/05/17 15:43:04 |
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Basic information
Public title
A validation study of algorithm for treatment of nursing-healthcare associated pneumonia
Acronym
Algorithm for treatment of NHCAP
Scientific Title
A validation study of algorithm for treatment of nursing-healthcare associated pneumonia
Scientific Title:Acronym
Algorithm for treatment of NHCAP
Region
| Japan |
Condition
Condition
Nursing-healthcare associated pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the validity of PCT-algorithm which decides the duration of antibiotics therapy for NHCAP, mainly choosing SBT/ABPC or CTRX.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital mortality and relapses of pneumonia occurring within 30 days following admission
Key secondary outcomes
Initial choice of antibiotics, the number of drug-change and duration of therapy.
Detection of drug-resistant bacteria.
The rate of blood culture-positive.
Identification of poor prognostic factor.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Algorithm for treatment of NHCAP
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as NHCAP, and classified into treatment category B or C.
Key exclusion criteria
(1) Known severe allergy to any drugs.
(2) Patients with renal failure.
(3) Fatal and severe underlying disease, malignancy, COPD, heart failure and so on.
(4) Patients who cannot keep quiet in bed or receive a course of injections, because of dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ogasawara |
Organization
Hamamatsu medical center
Division name
The department of respiratory medicine
Zip code
Address
328 Tomitsuka, Hamamatsu, Shizuoka
TEL
0534537111
shikatarawasgao@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ogasawara |
Organization
Hamamatsu medical center
Division name
The department of respiratory medicine
Zip code
Address
328 Tomitsuka, Hamamatsu, Shizuoka
TEL
0534537111
Homepage URL
shikatarawasgao@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
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
| 2013 | Year | 06 | Month | 15 | 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
| 2013 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 17 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012841
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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