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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003308
Receipt No. R000004000
Scientific Title A study on virus-associated community-acquired pneumonia in adults in rural Thailand
Date of disclosure of the study information 2010/03/09
Last modified on 2010/03/09

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Basic information
Public title A study on virus-associated community-acquired pneumonia in adults in rural Thailand
Acronym Virus-associated CAP study
Scientific Title A study on virus-associated community-acquired pneumonia in adults in rural Thailand
Scientific Title:Acronym Virus-associated CAP study
Region
Asia(except Japan)

Condition
Condition Virus- associated community-acquired pneumonia
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are ; 1) to determine the prevalence of etiologies of respiratory viruses and bacterial pathogens, and 2) to determine whether the detection of certain respiratory viruses could be risk factors of the occurrence or the outcome of pneumonia in adults.
Basic objectives2 Others
Basic objectives -Others 1. This study will be carried out on the basis of the routine clinical examinations without invasive procedures for diagnosing bacterial and viral etiologies for CAP in adults. The patients with CAP will be enrolled by clinical symptoms and an infiltrative shadow compatible with pneumonia on chest radiograph. The severity of CAP was evaluated according to the prediction rule of the IDSA/ ATS guidelines (11).
2. Microbiological examinations will be carried out for the enrolled patients with CAP. The examinations include sputum and blood culture, rapid antigen tests for influenza virus A and B, respiratory syncytial (RS) virus, and urinary antigen test for S. pneumoniae, and the real-time PCR for seasonal influenza virus and S-OIV H1N1 using swab samples in cases with positive influenza virus antigens or the cases suspected for influenza clinically.
3. This study will be conducted between March 2009 and March 2011.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes This study may provide:
1) the incidence of virus-associated CAP in adults in Thailand
2) the incidence of virus-associated pneumococcal CAP in adults in Thailand
3) the incidence and clinical characteristics of severe diseases in adult patients with S-OIV associated CAP
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients with CAP within 24 h of admission without any effective treatments will be included for the study after receiving the written informed consent. Pneumonia will be diagnosed as a new pulmonary infiltrate found on the chest radiograph and symptoms and signs of lower respiratory tract infection at admission.
Key exclusion criteria Patients with immunosuppression, such as patients with neutropenia after chemotherapy, patients with drug-induced immunosuppression as a result of corticosteroid or cytotoxic therapy or patients with HIV-related condition will be excluded from this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Oishi
Organization Research Institute for Microbial Diseases, Osaka University
Division name International Research Center for Infectious Diseases
Zip code
Address 3-1 Yamadaoka, Suita, Osaka Prefecture
TEL 06-6879-4253
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Oishi
Organization Research Institute for Microbial Diseases, Osaka University
Division name International Research Center for Infectious Diseases
Zip code
Address 3-1 Yamadaoka, Suita, Osaka Prefecture
TEL 06-6879-4253
Homepage URL
Email oishik@biken.osaka-u.ac.jp

Sponsor
Institute International Research Center for Infectious Diseases, Research Institute for Microbial Diseases, Osaka University
Institute
Department

Funding Source
Organization Program of Emerging and Reemerging Infectious Diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Buddhachinaraj Hospital, Phitsanulok Province, Thailand
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 Department of Medicine, Buddhachinaraj Hospital, Thailand

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 09 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 Open public recruiting
Date of protocol fixation
2009 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 04 Month 01 Day
Date analysis concluded
2010 Year 08 Month 01 Day

Other
Other related information
All cases of community-acquired pneumonia (CAP) in adults were recorded at a tertiary hospital in Phitsanulok between April and November, 2009, and the CAP cases were prospectively examined for pdm H1N1 virus infections by real-time PCR from July, 2009. All cases showing a positive PCR were investigated for clinical features including bacterial infection and severity of the disease, course of admission, treatment and outcome.
Twenty-four adult cases of pdm H1N1 virus-associated CAP were confirmed between July and October. The median age of these cases was 39.5 years. Most of cases appeared to be primary viral pneumonia, but only one case tested positive for a urinary pneumococcal antigen. The median time from the onset of illness to admission was 4 days. All of 24 patients received oseltamivir after admission, 12 (50.0 %) were defined as having severe CAP and required mechanical ventilation and 9 (37.5%) were diagnosed with acute respiratory distress syndrome (ARDS). Five patients died and 19 patients survived. Three patients with ARDS died of ventilator-associated pneumonia (VAP) caused by multidrug-resistant (MDR) Acinetobacter baumannii. The factors associated with death were severe CAP, ARDS, and VAP caused by MDR A. baumannii.

Management information
Registered date
2010 Year 03 Month 09 Day
Last modified on
2010 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004000

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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