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Point of Care Streptococcal Pharyngitis Testing

NCT03744832 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2022-05-18

No results posted yet for this study

Summary

Sore throat is a common problem in children typically caused by viral or bacterial infections. While viral infections resolve without treatment, bacterial infections, such as "strep throat," are treatable with antibiotics. Diagnosing "strep throat" traditionally required a throat swab for culture that delays treatment for several days. This may result in prolonged illness, activity absenteeism, and significant healthcare costs. New molecular tests can accurately diagnose "strep throat" within 8 minutes, but are more expensive and require impact evaluation before widespread implementation. This study will compare a new bedside molecular test with conventional throat cultures to evaluate for benefits to patients and families seen in the emergency department, as well to healthcare system operations. The investigators hypothesize that care for children and the associated healthcare costs will improve with these point of care molecular tests.

Conditions

  • Pharyngitis Acute

Interventions

DIAGNOSTIC_TEST

Alere i™ Strep A assay

Point of care (POC) molecular-based, nucleic acid amplification test (NAAT). This isothermal molecular assay is CLIA waived (Clinical Laboratory Improvement Amendments) and Health Canada licensed for POC use, and is anticipated to have approval for use without need for back up culture testing.

DIAGNOSTIC_TEST

Throat culture

Standard bacterial throat culture.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2021-12-23
Completion
2022-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744832 on ClinicalTrials.gov