A Comparison of Respiratory Sample Collection by a Parent or by a Healthcare Worker

NCT00966069 | Completed

• 1 other identifier: HREC/09/QRCH/42
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infections

Keywords

Respiratory tract infections; Viral infections; Pediatrics; Specimen collection

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (2)

• Proportion of specimens collected that have a virus able to be detected.

  6 months

• Proportion of swabs collected at home visit with virus detected (HCW nasopharyngeal swab vs parent collected anterior nose swab).

  6 months

Study Arms (2)

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.

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.

Other: Parent collection

Interventions

Parent collection OTHER

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

Parent collection

Healthcare worker home visit OTHER

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

Healthcare worker visit

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

Queensland Children's Medical Research Institute

Brisbane, Queensland, 4029, Australia

Location

Related Publications (1)

• 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.

  PMID: 30657971 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Keith Grimwood, MD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

• Theo P Sloots, PhD

  Queensland Paediatric Infectious Diseases Laboratory

  PRINCIPAL INVESTIGATOR

• Michael D Nissen, FRACP

  Queensland Paediatric Infectious Disease Laboratory

  PRINCIPAL INVESTIGATOR

• Stephen B Lambert, MBBS

  Queensland Paediatric Infectious Diseases Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 26, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)