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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010972
Receipt No. 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

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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
Email 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
Email shikatarawasgao@gmail.com

Sponsor
Institute Department of Respiratory Medicine, Hamamatsu Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012841

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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