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Feasibility and clinical impact of rapid respiratory virus testing in a real-world setting

A pragmatic randomized controlled trial of rapid on-site influenza and respiratory syncytial virus PCR testing in pediatric and adult populations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10110119
Enrollment
328
Registered
2021-12-01
Start date
2020-01-06
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza and respiratory syncytial virus Infections and Infestations Influenza, virus not identified

Interventions

Patients with a respiratory viral testing order are randomized to testing at either a central accredited laboratory with a respiratory pathogen panel nucleic acid test (standard arm) or with a rapid p

Sponsors

University of Calgary
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients with a respiratory virus nucleic acid test ordered by a physician at one of the two study hospitals

Exclusion criteria

Exclusion criteria: Patients without a respiratory virus nucleic acid test ordered by a physician at one of the two study hospitals

Design outcomes

Primary

MeasureTime frame
1. Turnaround time for the rapid NAT or standard of care test, as measured from the time of collection of the sample to the verification of the result. Time of collection submitted by the collector and recorded in the laboratory information system (LIS). Time of result is when reported by the laboratory in the LIS. Times will be retrieved from the LIS at the end of the study. 2. Pediatric site (site 1) - Duration of hospital stay for patients tested for respiratory viruses, defined as the time from ER admission to hospital discharge or hospital admission to hospital discharge if ER admission time is not available. Patients seen only in ER will not be included in this endpoint. This is recorded in the clinical information system (CIS) and will be retrieved from there. 3. Adult/pediatric site (site 2) – a prescription of oseltamivir recorded in the CIS during the encounter. Data will be retrieved from the CIS.

Secondary

MeasureTime frame
All secondary outcome measures are recorded in the clinical information system as a part of routine care and will be retrieved from there at the end of the study: 1. A prescription of oseltamivir ordered during the encounter for site 1 2. Number of oseltamivir doses administered during the encounter 3. Time from the patient’s encounter start time to receipt of their first oseltamivir dose (if oseltamivir given) 4. A chest x-ray ordered* 5. Number of ancillary laboratory tests ordered* 6. A prescription of bacterial antimicrobial agents ordered* 7. Duration of emergency department stay if not admitted to hospital determined by the time of admission to discharge *Orders for chest-x-rays, ancillary tests, antimicrobial agents (#3-6) will be included if they are ordered from the time of the respiratory virus NAT order to 24 h after the respiratory pathogen panel is resulted (standard test performed in standard arm and intervention arm after rapid onsite testing).

Countries

Canada

Contacts

Public ContactByron Berenger
byron.berenger@ucalgary.ca+1 (0)587 779 5573

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026