UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003368 |
|---|---|
| Receipt number | 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 09:45:22 |
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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
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
Sponsor or person
Institute
Nagasaki evaluation organization for clinical interventions
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004095
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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