UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005512 |
|---|---|
| Receipt number | R000006536 |
| Scientific Title | Clinical evaluation of measurement of Toll-like receptor 2 and CD64 receptor on peripheral blood mononuclear cell in pneumonia patients |
| Date of disclosure of the study information | 2011/04/27 |
| Last modified on | 2012/11/13 13:58:30 |
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Basic information
Public title
Clinical evaluation of measurement of Toll-like receptor 2 and CD64 receptor on peripheral blood mononuclear cell in pneumonia patients
Acronym
Clinical evaluation Toll-like receptor 2 and CD64 receptor measurement on PBMC in pneumonia patients
Scientific Title
Clinical evaluation of measurement of Toll-like receptor 2 and CD64 receptor on peripheral blood mononuclear cell in pneumonia patients
Scientific Title:Acronym
Clinical evaluation Toll-like receptor 2 and CD64 receptor measurement on PBMC in pneumonia patients
Region
| Japan |
Condition
Condition
Community-acquired pneumonia, Hospital-acquired pneumonia, Healthcare-associated pneumonia
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of transition of Toll-like receptor (TLR)2 and CD64 expression on peripheral blood mononuclear cell (PBMC) in pneumonia patients. Comparison between expression of these receptors on PBMC with several cytokines and procalcitonin (PCT).
Ordinal inflammatory markers such as white blood cell counts, c-reactive protein and IK-6 are not perfect markers for evaluating severity of infectious diseases, because these are easily influenced by underlying diseases, administration of immunosuppressive agents and patient clinical history. Newer and reliable markers are urged to be developed in clinical practice. The main objective of this study is that quantification of TLR2 and CD64 expression on PBMC may contribute to evaluation of severity and prognosis of pneumonia patients with high sensitivity.
Basic objectives2
Others
Basic objectives -Others
Evaluation of relation between severity of pneumonia, common inflammatory markers and expression of TLR2 and CD64 on PBMC.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Evaluation of relation between severity of pneumonia and expression of TLR2 and CD64 on PBMC of pneumonia patient. Severity of pneumonia is defined by A-DROP, PSI, I-ROAD, and their combinations.
(2) Evaluation of relation between common inflammatory markers and expression of TLR2 and CD64 on PBMC of pneumonia patient. Common inflammatory markers are C-reactive proteins, white blood cell count, cytokines and procalcitonin.
(3) Evaluation of relation between patient outcome and prognosis and expression of TLR2 and CD64 on PBMC of pneumonia patient.
(4) Evaluation of relation between causative agents and expression of TLR2 and CD64 on PBMC of pneumonia patient.
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
1. New infiltrates on chest X-ray films including CT and fulfill at least one of following two conditions;
1) inflammatory findings
(1)Fever; over 37 C
(2)Increase of WBC
(3)Positive CRP
2)clinical symptoms
(1)Cough
(2)Purulent sputum or deterioration of sputum
(3)Abnormal findings in auscultation and percussion of chest
(4)Deterioration of dyspnea, tachypnea or increase of respiratory rate
(5)Hypoxia
2. Patients who are agreed to participate to this study with informed consents
3. Both of outpatient and inpatient can participate to this study
Key exclusion criteria
The following patients were excluded from the study:
(1) patients received any antibiotics prior to this study,
(2) patients received immunosuppressive agents,
(3) patients with taking steroids (more than 10mg/day as predonisolone),
(4) patients who were not considered as participant by attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kohno |
Organization
Nagasaki University Hospital
Division name
Director
Zip code
Address
1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL
095-819-7273
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Izumikawa |
Organization
Nagasaki evaluation organization for clinical interventions
Division name
office
Zip code
Address
TEL
Homepage URL
shinkin@peath.co.jp
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
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
長崎大学病院（長崎県）
日本赤十字社長崎原爆諫早病院（長崎県）
日本赤十字社長崎原爆病院（長崎県）
健康保険諫早総合病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 27 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2011 | Year | 04 | Month | 26 | Day |
Last modified on
| 2012 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006536
