Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001006235
Ethics application status
Approved
Date submitted
18/11/2009
Date registered
20/11/2009
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central Australia Swab Study: an assessment of circulating respiratory pathogens in a remote Indigenous community
Scientific title
A pilot study to assess the presence of circulating respiratory pathogens in a remote Indigenous community using different specimen transport methods and sensitive molecular techniques
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Viral respiratory infections 252233 0
Condition category
Condition code
Infection 252419 252419 0 0
Studies of infection and infectious agents
Public Health 252435 252435 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nasal swabs from people with and without respiratory symptoms presenting to the community clinic over a 3 week period that are sent to the laboratory by routine mail. Two anterior nasal swabs are collected from each participant. The L nare specimen is sent by mail and the R nare specimen is transported frozen.
Intervention code [1] 241566 0
Diagnosis / Prognosis
Comparator / control treatment
Nasal swabs from people with and without respiratory symptoms presenting to the community clinic over a 3 week period that are sent to the laboratory frozen. Two anterior nasal swabs are collected from each participant. The L nare specimen is sent by mail and the R nare specimen is transported frozen.
Control group
Active

Outcomes
Primary outcome [1] 253293 0
The proportion of nasal swabs that are positive for influenza virus by real-time polymerase chain reaction(PCR) in those that are sent by post compared to those that sent by frozen
Timepoint [1] 253293 0
Single study visit
Secondary outcome [1] 262327 0
The prevalence of circulating respiratory viruses present in the nasopharynx in are remote Indigenous community. Viruses to be tested for include:
1. adenovirus
2. Respiratory Syncytial Virus (RSV),
3. influenza,
4. Parainfluenza Virus (PIV) types 1,2,3
5. Human Metapneumovirus (hMPV),
6. Rhinoviruses (RVs),
7. Human Coronaviruses (hCOV),
8. Bocavirus
9. Karolinska Institute Virus (KI)
10. Washington University Virus (WU)
Timepoint [1] 262327 0
Single study visit

Eligibility
Key inclusion criteria
1. Resident in a remote Indigenous community in the 14 days prior to the study visit.

2. Provision of written informed consent
Minimum age
0 Days
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/08/2009
Actual
12/08/2009
Date of last participant enrolment
Anticipated
Actual
31/08/2009
Date of last data collection
Anticipated
Actual
31/08/2009
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244043 0
University
Name [1] 244043 0
Menzies School of Health Research
Country [1] 244043 0
Australia
Funding source category [2] 244044 0
University
Name [2] 244044 0
Centre for Clinical Research Excellence in Child and Adolescent Immunisation
Country [2] 244044 0
Australia
Funding source category [3] 244045 0
Commercial sector/Industry
Name [3] 244045 0
GlaxoSmithKline Australia - Biologicals
Country [3] 244045 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina NT 0811
Country
Australia
Secondary sponsor category [1] 251390 0
University
Name [1] 251390 0
Centre for Clinical Research Excellence in Child & Adolescent Immunisation
Address [1] 251390 0
School of Population Health
University of Melbourne, VIC, 3010
Country [1] 251390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258141 0
Central AustraliaHuman Research Ethics Committee
Ethics committee address [1] 258141 0
Centre for Remote Health
PO Box 4066
Alice Springs NT 0871
Ethics committee country [1] 258141 0
Australia
Date submitted for ethics approval [1] 258141 0
09/02/2009
Approval date [1] 258141 0
04/08/2009
Ethics approval number [1] 258141 0
4/02/2009

Summary
Brief summary
The primary purpose of this study is determine the best method for transporting respiratory specimens for viral studies from remote Indigenous communities. The study will enable planning for respiratory illness surveillance and interventions in remote areas.

The primary hypothesis is that there is no difference in the proportion of respiratory viruses detected in nasal swabs collected from children and adults in the community that have been frozen immediately compared to specimens that have been sent via routine post.
Trial website
Nil
Trial related presentations / publications
1. O'Grady KF, Torzillo PJ, Rockett R, Whiley DM, Sloots T, Nissen MD, Lambert SB. Successful application of a simple transport method for the conduct of respiratory virus surveillance in remote Indigenous communities in Australia. Trop Med Int Health. 2011. 16(6): 766-772

2. O’Grady KF, Whiley DM, Torzillo PJ, Sloots TP, Lambert SB. Mailed versus frozen transport of nasal specimens for bacterial PCR. BMC Infectious Diseases. 2013 Nov 14;13:543
Public notes

Contacts
Principal investigator
Name 30523 0
Address 30523 0
Country 30523 0
Phone 30523 0
Fax 30523 0
Email 30523 0
Contact person for public queries
Name 13770 0
Kerry-Ann O'Grady
Address 13770 0
Menzies School of Health Research
PO Box 41096
Casuarina, NT, 0811
Country 13770 0
Australia
Phone 13770 0
+61 8 8922 6969
Fax 13770 0
Email 13770 0
[email protected]
Contact person for scientific queries
Name 4698 0
Kerry-Ann O'Grady
Address 4698 0
Menzies School of Health Research
PO Box 41096
Casuarina, NT, 0811
Country 4698 0
Australia
Phone 4698 0
+61 8 8922 6969
Fax 4698 0
Email 4698 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIMailed versus frozen transport of nasal swabs for surveillance of respiratory bacteria in remote Indigenous communities in Australia2013https://doi.org/10.1186/1471-2334-13-543
N.B. These documents automatically identified may not have been verified by the study sponsor.