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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00966069




Registration number
NCT00966069
Ethics application status
Date submitted
24/08/2009
Date registered
25/08/2009
Date last updated
16/03/2016

Titles & IDs
Public title
A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker
Scientific title
ReSPeCT: An Unblinded, Randomised, Controlled Trial to Compare Respiratory Sample Collection by a Parent or by a Healthcare Worker at a Home Visit
Secondary ID [1] 0 0
HREC/09/QRCH/42
Universal Trial Number (UTN)
Trial acronym
ReSPeCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 0 0
Respiratory Tract Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Parent collection
Other interventions - Healthcare worker home visit
Other interventions - Parent collection
Other interventions - Healthcare worker home visit

Active Comparator: Healthcare worker visit - Healthcare worker performs home visit when study child has acute respiratory illness to collect a respiratory swab (nasopharyngeal swab).
At the healthcare worker home visit, the HCW will collect the nasopharyngeal swab, and a parent will collect an anterior nasal swab. The HCW swab is to be returned immediately to the laboratory, and the parent collected swab was placed in a post box for return to the laboratory by surface mail.

Experimental: Parent collection - Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness.

Active Comparator: Healthcare worker visit - Healthcare worker performs home visit when study child has acute respiratory illness to collect a respiratory swab (nasopharyngeal swab).
At the healthcare worker home visit, the HCW will collect the nasopharyngeal swab, and a parent will collect an anterior nasal swab. The HCW swab is to be returned immediately to the laboratory, and the parent collected swab was placed in a post box for return to the laboratory by surface mail.

Experimental: Parent collection - Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness.


Other interventions: Parent collection
Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.

Other interventions: Healthcare worker home visit
Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.

Other interventions: Parent collection
Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.

Other interventions: Healthcare worker home visit
Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory. - For this outcome, the Investigators will compare the proportion of all incident ARIs that have a specimen available for testing in each group (HCW vs parent collection).
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory. - For this outcome, the Investigators will compare the proportion of all incident ARIs that have a specimen available for testing in each group (HCW vs parent collection).
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Proportion of specimens collected that have a virus able to be detected. - For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in each group (HCW vs parent collection) that have any virus detected.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab). - This comparison is restricted to children randomised to the health care worker collection group. In this group, at the home visit the HCW will collect a nasopharyngeal swab, place it in universal transport media, and return it immediately to the laboratory. At the same home visit, a parent will collect a dry anterior nasal swab, it will be placed in a post box near the subject's home, and returned to the laboratory by normal surface mail. For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in the HCW group that have any virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Proportion of specimens collected that have a virus able to be detected. - For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in each group (HCW vs parent collection) that have any virus detected.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab). - This comparison is restricted to children randomised to the health care worker collection group. In this group, at the home visit the HCW will collect a nasopharyngeal swab, place it in universal transport media, and return it immediately to the laboratory. At the same home visit, a parent will collect a dry anterior nasal swab, it will be placed in a post box near the subject's home, and returned to the laboratory by normal surface mail. For this outcome, the Investigators will compare the proportion of all specimens collected during incident ARIs in the HCW group that have any virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).
Timepoint [4] 0 0
6 months

Eligibility
Key inclusion criteria
- healthy children, 0 to 23 months of age at enrolment (not reached their 2nd birthday)

- born between 36 and 42 weeks gestational age

- written informed consent from parent/guardian (available for telephone contact)

- parent willing to collect an anterior nasal specimen from the study child when meets
criteria for ARI of interest
Minimum age
No limit
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- children with chronic pulmonary or cardiovascular disorders (including diagnosed
asthma, or frequent use of asthma medication)

- children with chronic metabolic disorders (such as but not limited to diabetes
mellitis, renal dysfunction, haemoglobinopathies)

- children with immune system disorders (such as HIV/AIDS or receiving immune system
suppressing medications)

- children with other chronic illnesses whose enrolment is deemed by the investigators
to make it inappropriate to enrol them onto the study

- parent or guardian with sufficient English language skills to complete study diaries
and perform study tasks as required

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Children's Medical Research Institute - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Children's Medical Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigators are aiming to learn more about respiratory infections in young children in
the community. To prepare for a larger project, the investigators are conducting this study
to get information about the best way to collect and transport respiratory specimens from
young children. The investigators would like to test whether parents are more likely to
collect a simple respiratory specimen themselves during a child's illness, compared to the
likelihood of specimen collection when a home visit is made by a health care worker. Further,
the investigators want to compare the likelihood a virus will be identified in both groups.
Trial website
https://clinicaltrials.gov/show/NCT00966069
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith Grimwood, MD
Address 0 0
Queensland Children's Medical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications