Clinical trial NCT00966069: A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Respiratory tract infections
Viral infections
Pediatrics
Specimen collection
Lead sponsor: The University of Queensland
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 64
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory.
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of specimens collected that have a virus able to be detected.
timeFrame: 6 months
measure: Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).
timeFrame: 6 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Queensland Children's Medical Research Institute
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Keith Grimwood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Paediatric Infectious Diseases Laboratory
name: Theo P Sloots, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Paediatric Infectious Disease Laboratory
name: Michael D Nissen, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Queensland Paediatric Infectious Diseases Laboratory
name: Stephen B Lambert, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.