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Respiratory InfectionNCT00278759

Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

A study testing Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit. in people with Respiratory Infection, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute respiratory tract infections are among the most common problems of childhood, particularly among infants and children younger than 3 years, and account for most antibiotic prescriptions to children. Read more about this study

Who is it for?
Ages 3 to 36 monthsHealthy volunteers can take part
Conditions the study is for
Respiratory Infection
What is being tested?
Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.
Type of treatment
Surgery or procedure
How many people
275 participants
Where
1 siteCanada
Study dates
Dec 2005to Dec 2007
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 3 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Admitted to the BCCH ED with fever (≥38.5 0C) and one or more of the following:
  • cough,
  • runny nose,
  • sore throat, or
  • congested nose.

Who cannot join

  • Excluded from the study will be patients who are:
  • immuno-compromised,
  • have chronic severe respiratory conditions (cystic fibrosis, bronchopulmonary dysplasia),
  • chronic heart conditions or
  • who is in severe distress requiring immediate care or resuscitation, or
  • have had prior assessment in our ED department for the current illness.
  • Only one child per family can be enrolled.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Children's and Women's Health Centre of BC

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

About this study

Official title: Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics. A Randomized Controlled Trial of Decision Making Based Upon Early (at Triage) Rapid Diagnosis of Respiratory Viral Infections (VIRAP) in Children 3-36 Months of Age Presenting to the Emergency Department (ED) With a Flu-Like Illness.

Acute respiratory tract infections are among the most common problems of childhood, particularly among infants and children younger than 3 years, and account for most antibiotic prescriptions to children. Most of these infections are self-limited and do not require medical intervention; however, the symptoms overlap significantly with those of severe viral or bacterial infections. At the hospital Emergency Department (ED), medical assessment, prescription of antibiotics (unnecessarily if the infection is viral), and a series of investigations (e.g., blood work, X-rays) often take place before a decision on patient management and possible hospital admission can be made. Such procedures lead to intense use of human health resources (nursing, laboratory and radiology staff) and hospital facilities.

The literature suggests that a prompt single viral diagnosis improves decision-making. To our knowledge, no-one has performed a controlled trial to examine the impact of a rapid, multi-viral detection test like VIRAP, or the impact of the timing of such a test, on management of children with flu-like illnesses in the ED.

Read more

Our objective is to determine if use of our new viral detection program, VIRAP, for rapid testing for viral respiratory infections right after triage will improve patient management and resource use in the ED. We will test the hypothesis that availability of VIRAP at triage to support rapid diagnosis of viral infection in children at BCCH will (i) reduce the waiting time in the ED; (ii) improve decision making regarding diagnostic investigations and specimen collection; and (iii) decrease antibiotic prescriptions.

Study completed and manuscript accepted for publication in the Journal of Pediatrics.

Read the detailed description

Description of Project:

Background: Acute viral respiratory tract infections are among the most common infectious problems of childhood during the first five years of life, particularly among infants younger than 2 years of age. Although the majority of these infections does not require medical attention and are self-limited in nature, worried parents commonly bring their children to the emergency department (ED) for evaluation (average 2500 children/winter). EDs are choke points in the health care system, especially at the peaks of the annual influenza season and respiratory syncytial virus (RSV) season. Without a prompt specific viral diagnosis in a child presenting to the ED with a febrile respiratory illness, after being seen by a physician, a child may have to undergo a constellation of precautionary diagnostic tests (septic work up, CXR) and be prescribed antibiotics unnecessarily. These interventions lead to prolonged ED stays (average 180min +/-120 min), intense use of human health resources (nursing, laboratory and radiology staff) resulting in significant cost both direct and indirect to the health care system, as well as time lost to the children and their families and contribute to antimicrobial resistance. The precise etiology of these viral infection episodes can be determined through the use of rapid screening program such as VIRAP (nasopharyngeal washing for rapid direct viral antigen detection via immunofluorescence). At the moment VIRAP is a physician ordered test, done only after the child has been seen by the physician, usually after the child has already been waiting for a significant length of time, then has to wait further for the results of the test.

Hypothesis: Rapid diagnosis of viral infection through VIRAP initiated by a nurse at triage wit results available for ED physician time of assessment may influence decision making with respect to additional investigations therefore reduce the amount of waiting time in the ED, as well as decrease antibiotic prescriptions. This would ultimately result in improved effectiveness of service provision for children with febrile respiratory illnesses and in turn shorten waiting time for all children in the ED. Health care cost reduction by minimising unnecessary diagnostic tests being performed and antibiotic prescription are also expected.

Study design: We propose to conduct a single centre, open label, randomized controlled trial comparing outcomes of patients undergoing VIRAP at triage vs routine ED admission protocol. During the months of December 2005 to April, and again Dec2006 to April 2007, eligible patients based on our inclusion and exclusion will be enrolled at triage and randomized in a 1:1 ratio to either undergo NPW for VIRAP and have the result available to the treating physician at time of assessment or routine admitting protocol to the ED and await physician assessment without prior investigation.

Criteria: Patients age 3-36 months admitted to the BCCH ED with fever(≥38.5 0C measured in ED or documented by the accompanying parent) and at least one of: cough, runny nose, nasal congestion and sore throat will be eligible for enrolment. Excluded from the study will be patients who are immuno-compromised, who have underlying chronic severe respiratory conditions (cystic fibrosis, bronchopulmonary dysplasia) or chronic heart conditions (uncorrected cyanotic heart lesions, prosthetic valves), who have had prior assessment in our ED department for the current illness. Only one child per family can be enrolled.

End points: The duration of stay in ED (from assessment to discharge, including time waiting for investigations and review of results by the physician) is the primary endpoint. Secondary endpoints include whether any investigations following the assessment (blood test, radiographs or urine tests) were ordered and whether study patients were prescribed antibiotics.

Being tested
Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.
Keywords
rapid viral diagnosis, respiratory infection, pediatric emergency department, febrile respiratory infection
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit.Procedure or surgery

    See Detailed Description.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Emergency Department visit (from initial physician contact to discharge from Emergency Department)

Secondary outcomes (2)
  1. Rate of antibiotic prescription in Emergency Department.

  2. Rate of ancillary tests performed in Emergency Department.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278759
Sponsor's protocol ID
C05-0501
Status last verified
Aug 2008
First submitted
16 Jan 2006
Last updated
19 Feb 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit. in people with Respiratory Infection, run by University of British Columbia at 1 site in Canada.

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 5 inclusion and 7 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 19 Feb 2009. 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 Canada. 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?

Length of Emergency Department visit (from initial physician contact to discharge from Emergency Department). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Feb 2009.

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