Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

• Sponsor: South East Asia Infectious Disease Clinical Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT01048073
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH), University of Oxford (Other)
• Enrollment: 1,200
• Locations: 9
• Duration (Months): 7
• Patients Per Site: 133.3
• Patients Per Site Per Month: 19

Study Details

Study Description

Brief 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.

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

Condition or Disease	Intervention/Treatment	Phase
Lower Respiratory Tract Infection

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

• Study Type: Observational
• Actual Enrollment: 1200 participants
• Time Perspective: Cross-Sectional
• Official Title: Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Outcome Measures

Primary Outcome Measures

1. the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adequately stored respiratory specimens obtained from hospitalized patients suspected of lower respiratory tract infection and were tested for influenza.

Exclusion Criteria:

• Specimens stored at insufficient temperature

• Specimen volume is insufficient

• No demographic data available

• Specimen unsuitable for testing for other technical reasons

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Health Research and Development	Jakarta,		Indonesia
2	Siriraj Hospital	Bangkok,		Thailand
3	Queen Sirikit National Institute of Child Health	Bangkok		Thailand
4	National Hospital of Pediatrics	Hanoi		Vietnam
5	National Hospital of Tropical Diseases	Hanoi		Vietnam
6	Oxford University Clinical Research Unit	Hanoi		Vietnam
7	Children's Hospital No 1	Ho Chi Minh City		Vietnam
8	Children's Hospital No 2	Ho Chi Minh City		Vietnam
9	Hospital for Tropical Diseases	Ho Chi Minh City		Vietnam

Sponsors and Collaborators

• South East Asia Infectious Disease Clinical Research Network
• National Institute of Allergy and Infectious Diseases (NIAID)
• University of Oxford

Investigators

• Principal Investigator: Pilaipan Pilaipan Puthavathana, MD, Ph.D, Siriraj Hospital, Bangkok, Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

• Drews 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.
• 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.
• Roh 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.
• Tsang 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. Review.
• Yoo 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.
• Yuan 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.

• ClinicalTrials.gov Identifier: NCT01048073
• Other Study ID Numbers: SEA 019
• First Posted: Jan 13, 2010
• Last Update Posted: May 27, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: lower respiratory tract infection; non influenza; PCR assay
• Additional relevant MeSH terms: Respiratory Tract Infections

Study Results

No Results Posted as of May 27, 2011