Clinical trial NCT01048073: Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia
Official title: Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Respiratory Tract Infection
Keywords: lower respiratory tract infection
non influenza
PCR assay
Lead sponsor: South East Asia Infectious Disease Clinical Research Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Oxford
First posted: 2010-01-13
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta,
country: Indonesia
facility: National Institute of Health Research and Development
city: Bangkok,
country: Thailand
facility: Siriraj Hospital
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
city: Hanoi
country: Vietnam
facility: National Hospital of Pediatrics
city: Hanoi
country: Vietnam
facility: National Hospital of Tropical Diseases
city: Hanoi
country: Vietnam
facility: Oxford University Clinical Research Unit
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital No 1
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital No 2
city: Ho Chi Minh City
country: Vietnam
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Siriraj Hospital, Bangkok, Thailand
name: Pilaipan Pilaipan Puthavathana, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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. doi: 10.3343/kjlm.2007.27.6.420.