Non-influenza Etiologies of Acute Respiratory Illness in... | NCT01048073

Studies
Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

NCT01048073

Sponsor

South East Asia Infectious Disease Clinical Research Network

Status

Completed

Last Update Posted

May 27, 2011Estimated

Enrollment

1,200Actual

Phase

Not provided

Conditions

Lower Respiratory Tract Infection

Interventions

Not provided

Countries

Indonesia
Thailand
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2011

Last Update Posted Date

May 27, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

South East Asia Infectious Disease Clinical Research NetworkNETWORK

Collaborators

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
University of Oxford	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pilaipan Pilaipan Puthavathana, MD, Ph.D	Siriraj Hospital, Bangkok, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Health Research and Development		Jakarta			Indonesia
Queen Sirikit National Institute of Child Health

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18296108	Background	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.
18945321	Background	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.