Unclogging the Pediatric Emergency Room: Impact of Rapid Viral Diagnostics

NCT00278759 | Completed

• 1 other identifier: C05-0501
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Respiratory Infection

Keywords

rapid viral diagnosis; respiratory infection; pediatric emergency department; febrile respiratory infection

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Rate of antibiotic prescription in Emergency Department.

• Rate of ancillary tests performed in Emergency Department.

Interventions

Nasopharyngeal washing for viral antigen detection by immunofluorescence initiated early in ED visit. PROCEDURE

See Detailed Description.

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Michael Smith Foundation for Health Research: collaborator

Study Sites (1)

Children's and Women's Health Centre of BC

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Eva Thomas, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 19, 2009

Record last verified: 2008-08

Locations

CA (1)