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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Queensland Children's Medical Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Queensland Children's Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00966069
First received: August 24, 2009
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Respiratory Tract Infections
Other: Parent collection
Other: Healthcare worker home visit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Further study details as provided by Queensland Children's Medical Research Institute:

Primary Outcome Measures:
  • Proportion of acute respiratory illnesses that have a specimen available for testing in the laboratory. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of specimens collected that have a virus able to be detected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of swabs collected at home visit with virus detected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthcare worker visit
Healthcare worker performs home visit when study child has acute respiratory illness to collect a respiratory swab (anterior nose).
Other: Healthcare worker home visit
Healthcare worker performs home visit for collection of respiratory specimen (anterior nose) when study child has an acute respiratory illness.
Experimental: Parent collection
Home collection of respiratory swab (anterior nose) and mailed return when study subject has an acute respiratory illness.
Other: Parent collection
Parent collection of anterior nose specimen when child has an acute respiratory illness, and mailed return of the specimen to the laboratory.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966069

Locations
Australia, Queensland
Queensland Children's Medical Research Institute
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
Queensland Children's Medical Research Institute
Investigators
Principal Investigator: Keith Grimwood, MD Queensland Children's Medical Research Institute
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
  More Information

No publications provided

Responsible Party: Professor Keith Grimwood, Queensland Children's Medical Research Institute
ClinicalTrials.gov Identifier: NCT00966069     History of Changes
Other Study ID Numbers: HREC/09/QRCH/42
Study First Received: August 24, 2009
Last Updated: February 14, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Queensland Children's Medical Research Institute:
Respiratory tract infections
Viral infections
Pediatrics
Specimen collection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014