Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Lower Respiratory Tract Infection Clinical Trial

Official title:

Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048073
• Other study ID #: SEA 019
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: May 25, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: South East Asia Infectious Disease Clinical Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeThailand: Ethical CommitteeVietnam: Ministry of HealthIndonesia: Departement Kesehatan (Department of Health)
• Study type: Observational

Clinical 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.

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Locations

Country	Name	City	State
Indonesia	National Institute of Health Research and Development	Jakarta,
Thailand	Queen Sirikit National Institute of Child Health	Bangkok
Thailand	Siriraj Hospital	Bangkok,
Vietnam	National Hospital of Pediatrics	Hanoi
Vietnam	National Hospital of Tropical Diseases	Hanoi
Vietnam	Oxford University Clinical Research Unit	Hanoi
Vietnam	Children's Hospital No 1	Ho Chi Minh City
Vietnam	Children's Hospital No 2	Ho Chi Minh City
Vietnam	Hospital for Tropical Diseases	Ho Chi Minh City

Sponsors (3)

Lead Sponsor	Collaborator
South East Asia Infectious Disease Clinical Research Network	National Institute of Allergy and Infectious Diseases (NIAID), University of Oxford

Countries where clinical trial is conducted

Indonesia,  Thailand,  Vietnam, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection		12 months	No