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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003368
Receipt No. R000004095
Scientific Title Assessment of clinical usefulness of Procalcitonin (PCT) measurement in pneumonia patients
Date of disclosure of the study information 2010/04/01
Last modified on 2011/07/22

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Basic information
Public title Assessment of clinical usefulness of Procalcitonin (PCT) measurement in pneumonia patients
Acronym Assessment of PCT measurement in pneumonia patients
Scientific Title Assessment of clinical usefulness of Procalcitonin (PCT) measurement in pneumonia patients
Scientific Title:Acronym Assessment of PCT measurement in pneumonia patients
Region
Japan

Condition
Condition community-acquired pneumonia,
hospital-acquired pneumonia,
healthcare-associated pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The clinical usefulness of PCT will be assessed by comparing PCT,known as a bacterial septicemia marker, with currently available inflammation markers in the relation between severity and prognosis of CAP, HAP and HCAP patients.
The current clinical status and profiles of HCAPpatients will also being examined.
Basic objectives2 Others
Basic objectives -Others PCT
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Assessment of relation between severity and PCT values in each CAP, HAP and HCAP.
As indicators of severity, A-DROP and PSI systems are used for CAP, IROAD and PSI systems for HAP and A-DROP, IROAD and PSI systems for HCAP patients.

2) Assessment of relation between currently available inflammatory markers and PCT values in each CAP, HAP and HCAP patients.
Inflammatory markers used as comparators: CRP, white blood cell count (WBC)

3) Assessment of relation between patient prognosis and PCT values in each CAP, HAP and HCAP patients.

4) Assessment of relation between causative pathogens and PCT values in each ach CAP, HAP and HCAP patients.

5) Examination of current status and profiles of HCAP.
Differences between HCAP and CAP or HCAP will be compared in patient characteristics, laboratory findings and agents for initial treatment.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pneumonia patients who comply the existence of new infiltration shadow in chest X-rays or CT with at least one of inflamatory (1) and clinical (2) findings below:
(1) Inflammatory findings
- Fever: 37˚C or higher (axillary measurement)
- Leukocytosis (WBC> 10,000/mm3) or stab cells > 15% or leukopenia (WBC < 4500/mm3)
- CRP positive
(2) Clinical findings
- Cough
- Existence of purulent sputum or airway secreta, or deterioration of properties of sputum observed.
- Abnormal auscultation and percussion findings (moist rale, dullness on percussion, reduced respiratory sound, etc.)
- Dyspnea, hyperpnea, increased respiratory rate (> 30 / min), whichever is aggravated
- Hypoxemia
Key exclusion criteria 1) Patients already administered antibacterial agents for pneumonia before sample collection
2) Other patients judged to be inappropriate by the attending physician
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kohno, MD
Organization Nagasaki University
Division name School of Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7418
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Yamamoto, MD
Organization Nagasaki University
Division name School of Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Homepage URL
Email

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 Other
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
2010 Year 04 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
2010 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information The clinical usefulness of PCT will be assessed by comparing PCT,known as a bacterial septicemia marker, with currently available inflammation markers in the relation between severity and prognosis of CAP, HAP and HCAP patients.

Management information
Registered date
2010 Year 03 Month 24 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=R000004095

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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