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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005512
Receipt No. 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

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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
Email

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
Email shinkin@peath.co.jp

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

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006536

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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