NCT01048073

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

4 months

First QC Date

January 12, 2010

Last Update Submit

May 25, 2011

Conditions

Lower Respiratory Tract Infection

Keywords

lower respiratory tract infectionnon influenzaPCR assay

Outcome Measures

Primary Outcomes (1)

  • the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Specimens stored at insufficient temperature
  • Specimen volume is insufficient
  • No demographic data available
  • Specimen unsuitable for testing for other technical reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

National Institute of Health Research and Development

Jakarta, Indonesia

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

Siriraj Hospital

Bangkok, Thailand

Location

National Hospital of Pediatrics

Hanoi, Vietnam

Location

National Hospital of Tropical Diseases

Hanoi, Vietnam

Location

Oxford University Clinical Research Unit

Hanoi, Vietnam

Location

Children's Hospital No 1

Ho Chi Minh City, Vietnam

Location

Children's Hospital No 2

Ho Chi Minh City, Vietnam

Location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Related Publications (6)

  • 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.

    PMID: 18296108BACKGROUND

  • 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.

    PMID: 18945321BACKGROUND

  • 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.

    PMID: 18667596BACKGROUND

  • 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.

    PMID: 18988931BACKGROUND

  • 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.

    PMID: 18316781BACKGROUND

  • 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.

    PMID: 18160832BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* nose swab * throat swab * nasopharyngeal aspirate * nasal wash * tracheal aspirate * bronchoalveolar lavage

Study Officials

  • Pilaipan Pilaipan Puthavathana, MD, Ph.D

    Siriraj Hospital, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

ID(1)TH(2)VN(6)