Lower Respiratory Tract InfectionNCT01048073
Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia
An observational study of Lower Respiratory Tract Infection, run by South East Asia Infectious Disease Clinical Research Network at 9 sites in 3 countries.
Trial summary
Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Respiratory Tract Infection
- How many people
- 1,200 participants
- Where
- 9 sitesin 3 countries
- Study dates
- May 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients with lower respiratory tract infection and were tested for influenza. These patients are admitted to South East Asia Influenza Clinical Research Network hospitals.
Who may be able to join
- Adequately stored respiratory specimens obtained from hospitalized patients suspected of lower respiratory tract infection and were tested for influenza.
Who cannot join
- Specimens stored at insufficient temperature
- Specimen volume is insufficient
- No demographic data available
- Specimen unsuitable for testing for other technical reasons
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Vietnam6 sites
National Hospital of Pediatrics
Hanoi
National Hospital of Tropical Diseases
Hanoi
Oxford University Clinical Research Unit
Hanoi
Children's Hospital No 1
Ho Chi Minh City
Children's Hospital No 2
Ho Chi Minh City
Hospital for Tropical Diseases
Ho Chi Minh City
Thailand2 sites
Queen Sirikit National Institute of Child Health
Bangkok
Siriraj Hospital
Bangkok
Indonesia1 site
National Institute of Health Research and Development
Jakarta
About this study
Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses.
The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia.
This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings
Read the detailed description
This study will test 1400 specimens from 1200 patients at the following laboratories:
- National Hospital of Pediatrics, Hanoi
- National Institute of Infectious and Tropical Diseases, Hanoi
- Siriraj Hospital, Bangkok
- National Institute of Health Research and Development, Jakarta
- Hospital for Tropical Diseases, HCMC
- Children Hospital #1, Ho Chi Minh City
- Children Hospital #2, Ho Chi Minh City
- Queen Sirikit National Institute of Child Health
- Conditions
- Lower Respiratory Tract Infection
- Keywords
- lower respiratory tract infection, non influenza, PCR assay
What is being measured
The primary outcome is the main question the study is designed to answer.
the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Asia Infectious Disease Clinical Research Network
- Sponsor type
- Research network
- Investigators
- Pilaipan Pilaipan Puthavathana, MD, Ph.D, Principal investigator, Siriraj Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048073
- Sponsor's protocol ID
- SEA 019
- Status last verified
- May 2011
- First submitted
- 12 Jan 2010
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
I P M, Nelson EA, Cheuk ES, Leung E, Sung R, Chan PK. Pediatric hospitalization of acute respiratory tract infections with Human Bocavirus in Hong Kong. J Clin Virol. 2008 May;42(1):72-4. doi: 10.1016/j.jcv.2007.12.016. Epub 2008 Mar 4.
PubMed 18296108Tsang KW, File TM Jr. Respiratory infections unique to Asia. Respirology. 2008 Nov;13(7):937-49. doi: 10.1111/j.1440-1843.2008.01409.x.
PubMed 18945321Yuan XH, Jin Y, Xie ZP, Gao HC, Xu ZQ, Zheng LS, Zhang RF, Song JR, Hou YD, Duan ZJ. Prevalence of human KI and WU polyomaviruses in children with acute respiratory tract infection in China. J Clin Microbiol. 2008 Oct;46(10):3522-5. doi: 10.1128/JCM.01301-08. Epub 2008 Jul 30.
PubMed 18667596Drews SJ, Blair J, Lombos E, DeLima C, Burton L, Mazzulli T, Low DE. Use of the Seeplex RV Detection kit for surveillance of respiratory viral outbreaks in Toronto, Ontario, Canada. Ann Clin Lab Sci. 2008 Autumn;38(4):376-9.
PubMed 18988931Roh KH, Kim J, Nam MH, Yoon S, Lee CK, Lee K, Yoo Y, Kim MJ, Cho Y. Comparison of the Seeplex reverse transcription PCR assay with the R-mix viral culture and immunofluorescence techniques for detection of eight respiratory viruses. Ann Clin Lab Sci. 2008 Winter;38(1):41-6.
PubMed 18316781Yoo SJ, Kuak EY, Shin BM. Detection of 12 respiratory viruses with two-set multiplex reverse transcriptase-PCR assay using a dual priming oligonucleotide system. Korean J Lab Med. 2007 Dec;27(6):420-7. doi: 10.3343/kjlm.2007.27.6.420.
PubMed 18160832
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia
- ClinicalTrials.gov ID
- NCT01048073
- Acronym / sponsor ID
- SEA 019
- Conditions
- Lower Respiratory Tract Infection
- Keywords
- lower respiratory tract infection, non influenza, PCR assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- South East Asia Infectious Disease Clinical Research NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of Oxford
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses.
The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia.
This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings
Detailed description
This study will test 1400 specimens from 1200 patients at the following laboratories:
- National Hospital of Pediatrics, Hanoi
- National Institute of Infectious and Tropical Diseases, Hanoi
- Siriraj Hospital, Bangkok
- National Institute of Health Research and Development, Jakarta
- Hospital for Tropical Diseases, HCMC
- Children Hospital #1, Ho Chi Minh City
- Children Hospital #2, Ho Chi Minh City
- Queen Sirikit National Institute of Child Health
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients with lower respiratory tract infection and were tested for influenza. These patients are admitted to South East Asia Influenza Clinical Research Network hospitals.
Key inclusion criteria (1 listed)
- Adequately stored respiratory specimens obtained from hospitalized patients suspected of lower respiratory tract infection and were tested for influenza.
Key exclusion criteria (4 listed)
- Specimens stored at insufficient temperature
- Specimen volume is insufficient
- No demographic data available
- Specimen unsuitable for testing for other technical reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
- Background: PubMed 18296108I P M, Nelson EA, Cheuk ES, Leung E, Sung R, Chan PK. Pediatric hospitalization of acute respiratory tract infections with Human Bocavirus in Hong Kong. J Clin Virol. 2008 May;42(1):72-4. doi: 10.1016/j.jcv.2007.12.016. Epub 2008 Mar 4.
- Background: PubMed 18945321Tsang KW, File TM Jr. Respiratory infections unique to Asia. Respirology. 2008 Nov;13(7):937-49. doi: 10.1111/j.1440-1843.2008.01409.x.
- Background: PubMed 18667596Yuan XH, Jin Y, Xie ZP, Gao HC, Xu ZQ, Zheng LS, Zhang RF, Song JR, Hou YD, Duan ZJ. Prevalence of human KI and WU polyomaviruses in children with acute respiratory tract infection in China. J Clin Microbiol. 2008 Oct;46(10):3522-5. doi: 10.1128/JCM.01301-08. Epub 2008 Jul 30.
- Background: PubMed 18988931Drews SJ, Blair J, Lombos E, DeLima C, Burton L, Mazzulli T, Low DE. Use of the Seeplex RV Detection kit for surveillance of respiratory viral outbreaks in Toronto, Ontario, Canada. Ann Clin Lab Sci. 2008 Autumn;38(4):376-9.
- Background: PubMed 18316781Roh KH, Kim J, Nam MH, Yoon S, Lee CK, Lee K, Yoo Y, Kim MJ, Cho Y. Comparison of the Seeplex reverse transcription PCR assay with the R-mix viral culture and immunofluorescence techniques for detection of eight respiratory viruses. Ann Clin Lab Sci. 2008 Winter;38(1):41-6.
- Background: PubMed 18160832Yoo SJ, Kuak EY, Shin BM. Detection of 12 respiratory viruses with two-set multiplex reverse transcriptase-PCR assay using a dual priming oligonucleotide system. Korean J Lab Med. 2007 Dec;27(6):420-7. doi: 10.3343/kjlm.2007.27.6.420.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilaipan Pilaipan Puthavathana, MD, Ph.D principal investigator
Siriraj Hospital, Bangkok, Thailand
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Tract Infection, run by South East Asia Infectious Disease Clinical Research Network at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Vietnam, Thailand, Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048073, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2011.