UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003308 |
|---|---|
| Receipt number | 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 18:49:24 |
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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
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
oishik@biken.osaka-u.ac.jp
Sponsor or person
Institute
International Research Center for Infectious Diseases, Research Institute for Microbial Diseases, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004000
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