Respiratory Tract InfectionsReSPeCTNCT00966069
A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker
A study testing Parent collection and Healthcare worker home visit in people with Respiratory Tract Infections, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Parent collection and Healthcare worker home visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Queensland Children's Medical Research Institute
Brisbane, Queensland, 4029
About this study
Official title: ReSPeCT: An Unblinded, Randomised, Controlled Trial to Compare Respiratory Sample Collection by a Parent or by a Healthcare Worker at a Home Visit
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.
Read the detailed description
Prior to this study, there had been one small study conducted in the Netherlands comparing parent-collected specimens at home with collection by a health care worker (HCW) during an arranged home visit. This study suggested that despite there being approximately the same number of illnesses identified in each group, the parent collection group had a higher proportion of ARIs with a specimen collected (43% vs 24%, parent vs HCW home visit), and a higher proportion of specimens tested positive for a virus (80% vs 67%), although neither of these findings was statistically significant.
In order to prepare for a larger, community based study, we would like to test these findings in our environment.
Community-based respiratory infection research has traditionally been conducted by home visit from a health care worker during illness to collect a sample, such as a nasopharyngeal aspirate. This method has the potential to result in non-reporting of illness or failure to collect a specimen due to the invasive nature of specimen collection or the difficulty arranging a home visit time that is convenient for parents and staff. This may bias findings and interfere with generalisability.
Home collection of a simple respiratory sample has recently been demonstrated as an easy and acceptable method of conducting community-based respiratory research. Members of our group were involved in a large, community-based study in Melbourne involving 234 children and their families over a 12-month period. On this study parents successfully kept daily respiratory symptom diaries and collected a combined nose-throat swab when the child had an illness that met the definition for an acute respiratory illness (ARI) of interest. These study methods were acceptable with 87% parents reporting, at the end of the study, they would have been willing to continue with the study for at least another year.
Since that study, parent collection of simple respiratory specimens has been further validated in the hospital setting and used in the home setting.
We have previously shown that a swab combined with viral transport medium-soaked sponge in a secure transport tube is an efficient and safe way of transporting respiratory swabs. The method complies with guidelines for the transport of clinical specimens. As part of this study, we will use this system to allow for the transport of respiratory specimens to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory through the normal surface mail, thereby allowing study families to manage specimen collection and return without the intervention of a study staff member.
Flocked swabs in combination with specific viral transport media have recently been added to specimen collection options, allowing for simple and sensitive specimen collection whilst avoiding more invasive nasopharyngeal aspirates or washes.
With this study, we plan to compare parent and health care worker collection using flocked swabs, and for some specimens they will be returned to the laboratory through normal surface mail.
- Conditions
- Respiratory Tract Infections
- Being tested
- Parent collection, Healthcare worker home visit
- Keywords
- Respiratory tract infections, Viral infections, Pediatrics, Specimen collection
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent collectionOther
Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.
Healthcare worker home visitOther
Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare worker visit | Active comparator | 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. Receives: Other: Healthcare worker home visit |
| Parent collection | Experimental | Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness. Receives: Other: Parent collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Stephen Lambert, The University of Queensland
- Investigators
- Keith Grimwood, MD, Principal investigator, The University of QueenslandTheo P Sloots, PhD, Principal investigator, Queensland Paediatric Infectious Diseases LaboratoryMichael D Nissen, FRACP, Principal investigator, Queensland Paediatric Infectious Disease LaboratoryStephen B Lambert, MBBS, Principal investigator, Queensland Paediatric Infectious Diseases Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966069
- Sponsor's protocol ID
- HREC/09/QRCH/42
- Acronym
- ReSPeCT
- Status last verified
- Mar 2016
- First submitted
- 24 Aug 2009
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zoch-Lesniak B, Ware RS, Grimwood K, Lambert SB. The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):134-141. doi: 10.1093/jpids/piy136.
PubMed 30657971
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReSPeCT: An Unblinded, Randomised, Controlled Trial to Compare Respiratory Sample Collection by a Parent or by a Healthcare Worker at a Home Visit
- ClinicalTrials.gov ID
- NCT00966069
- Acronym / sponsor ID
- ReSPeCT / HREC/09/QRCH/42
- Conditions
- Respiratory Tract Infections
- Keywords
- Respiratory tract infections, Viral infections, Pediatrics, Specimen collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prior to this study, there had been one small study conducted in the Netherlands comparing parent-collected specimens at home with collection by a health care worker (HCW) during an arranged home visit. This study suggested that despite there being approximately the same number of illnesses identified in each group, the parent collection group had a higher proportion of ARIs with a specimen collected (43% vs 24%, parent vs HCW home visit), and a higher proportion of specimens tested positive for a virus (80% vs 67%), although neither of these findings was statistically significant.
In order to prepare for a larger, community based study, we would like to test these findings in our environment.
Community-based respiratory infection research has traditionally been conducted by home visit from a health care worker during illness to collect a sample, such as a nasopharyngeal aspirate. This method has the potential to result in non-reporting of illness or failure to collect a specimen due to the invasive nature of specimen collection or the difficulty arranging a home visit time that is convenient for parents and staff. This may bias findings and interfere with generalisability.
Home collection of a simple respiratory sample has recently been demonstrated as an easy and acceptable method of conducting community-based respiratory research. Members of our group were involved in a large, community-based study in Melbourne involving 234 children and their families over a 12-month period. On this study parents successfully kept daily respiratory symptom diaries and collected a combined nose-throat swab when the child had an illness that met the definition for an acute respiratory illness (ARI) of interest. These study methods were acceptable with 87% parents reporting, at the end of the study, they would have been willing to continue with the study for at least another year.
Since that study, parent collection of simple respiratory specimens has been further validated in the hospital setting and used in the home setting.
We have previously shown that a swab combined with viral transport medium-soaked sponge in a secure transport tube is an efficient and safe way of transporting respiratory swabs. The method complies with guidelines for the transport of clinical specimens. As part of this study, we will use this system to allow for the transport of respiratory specimens to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory through the normal surface mail, thereby allowing study families to manage specimen collection and return without the intervention of a study staff member.
Flocked swabs in combination with specific viral transport media have recently been added to specimen collection options, allowing for simple and sensitive specimen collection whilst avoiding more invasive nasopharyngeal aspirates or washes.
With this study, we plan to compare parent and health care worker collection using flocked swabs, and for some specimens they will be returned to the laboratory through normal surface mail.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare worker visit | Active comparator | Other: Healthcare worker home visitHealthcare 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. |
| Parent collection | Experimental | Other: Parent collectionHome collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent collectionParent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory. | Other | Parent collection |
| Healthcare worker home visitHealthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness. | Other | Healthcare worker visit |
Primary outcome
Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory.
Time frame: 6 months
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).
2 secondary outcomes
Proportion of specimens collected that have a virus able to be detected.
Time frame: 6 months
Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 30657971Zoch-Lesniak B, Ware RS, Grimwood K, Lambert SB. The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):134-141. doi: 10.1093/jpids/piy136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Grimwood, MD principal investigator
The University of Queensland
Theo P Sloots, PhD principal investigator
Queensland Paediatric Infectious Diseases Laboratory
Michael D Nissen, FRACP principal investigator
Queensland Paediatric Infectious Disease Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent collection and Healthcare worker home visit in people with Respiratory Tract Infections, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.