Point of Care Streptococcal Pharyngitis Testing

NCT03744832 | Unknown

• 1 other identifier: H18-02371
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatrics; Emergency Department; Point of Care Testing; Group A Strep

Outcome Measures

Primary Outcomes (1)

• Sore throat resolution.

  Mean time in half-days from ED discharge to sore throat resolution (POC vs. standard).

  7 days.

Secondary Outcomes (8)

• Fever resolution.

  7 days.

• Appropriate antibiotic utilization by patients/families.

  7 days.

• Calls averted.

  7 days.

• Parental Absenteeism.

  7 days.

• Child Absenteeism

  7 days

Study Arms (2)

Point of Care Testing

EXPERIMENTAL

Point of care testing using the Alere i™ Strep A assay for patients randomized to this study arm when presenting with suspected streptococcal pharyngitis and having their throat swabbed. If test is positive, patients will be started on antibiotics prior to discharge from the ED. If test is negative, patients will not be started on antibiotics. At home, the patient family will be asked to complete an online survey and/or keep a written diary daily detailing their clinical course following discharge from the ED.

Diagnostic Test: Alere i™ Strep A assay

Standard Care

ACTIVE COMPARATOR

Conventional testing using a standard bacterial throat culture for patients randomized to this study arm when presenting with suspected streptococcal pharyngitis and having their throat swabbed. Patients will be discharged with a post-dated prescription and will be contacted in approximately 3 days if their culture results are positive to fill/take the antibiotics. At home, the patient family will be asked to complete an online survey and/or keep a written diary daily detailing their clinical course following discharge from the ED.

Diagnostic Test: Throat culture

Interventions

Alere i™ Strep A assay DIAGNOSTIC_TEST

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.

Point of Care Testing

Throat culture DIAGNOSTIC_TEST

Standard bacterial throat culture.

Standard Care

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 3-17 years of age who seek care in a ED with sore throat, and in whom the ED clinician is considering a throat swab for culture for suspected GAS pharyngitis. In addition, only English speaking families will be recruited.

You may not qualify if:

• Patients younger than 3 and older than 17 years of age will be excluded. In addition, patients who had a throat swab completed and/or were treated with antibiotics prior to presenting to the ED for the current illness, and patients with underlying cardiorespiratory illness will be excluded.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (1)

• Gill C, Chui C, Goldfarb DM, Meckler G, Doan Q. Molecular Point-of-Care Testing in the Emergency Department for Group A Streptococcus Pharyngitis : A Randomized Trial. Pediatr Emerg Care. 2024 Sep 1;40(9):632-637. doi: 10.1097/PEC.0000000000003154. Epub 2024 Mar 18.

  PMID: 38498934 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: August 12, 2019
• Primary Completion: December 23, 2021
• Study Completion: June 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)