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Trial record 19 of 633 for:    test AND point-of-care

Point of Care Streptococcal Pharyngitis Testing

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ClinicalTrials.gov Identifier: NCT03744832
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Quynh Doan, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Pharyngitis Acute Diagnostic Test: Alere i™ Strep A assay Diagnostic Test: Throat culture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point of Care Group A Streptococcal Testing in a Pediatric Emergency Department: A Randomized Controlled Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Point of Care Testing

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
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.

Active Comparator: Standard Care

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
Standard bacterial throat culture.




Primary Outcome Measures :
  1. Sore throat resolution. [ Time Frame: 7 days. ]
    Mean time in half-days from ED discharge to sore throat resolution (POC vs. standard).


Secondary Outcome Measures :
  1. Fever resolution. [ Time Frame: 7 days. ]
    Mean time in half-days from ED discharge to fever resolution (axillary temperature; POC vs. standard).

  2. Appropriate antibiotic utilization by patients/families. [ Time Frame: 7 days. ]
    Proportion of patients appropriately treated with antibiotics (ie. streptococcal-positive treated with antibiotics and streptococcal-negative not started on antibiotics. Families may decide to fill prescription without a positive culture result or families may obtain a prescription from elsewhere despite a negative POC test in the ED; POC vs. standard).

  3. Calls averted. [ Time Frame: 7 days. ]
    Number of patient calls averted (POC vs. standard).

  4. Parental Absenteeism. [ Time Frame: 7 days. ]
    Mean number of days away from work for a parent (measured by half day units; POC vs. standard).

  5. Child Absenteeism [ Time Frame: 7 days ]
    Mean number of days away from school/daycare for a child

  6. Healthcare return visits. [ Time Frame: 7 days. ]
    Proportion of patients with a least 1 ED re-visit or community healthcare facility visit for the same illness within 7 days (POC vs. standard).

  7. Length of stay. [ Time Frame: 7 days. ]
    length of stay (LOS) will be calculated from time of registration/triage until discharge (POC vs. standard).

  8. Ancillary testing. [ Time Frame: 7 days ]
    May include, but is not limited to, a complete blood count, urinalysis, urine culture, blood, culture, or neck/chest radiographs (POC vs. standard).



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744832


Contacts
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Contact: Quynh Doan, PhD, MDCM 604-875-3691 qdoan@bcchr.ca

Sponsors and Collaborators
University of British Columbia

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Responsible Party: Quynh Doan, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03744832     History of Changes
Other Study ID Numbers: H18-02371
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Quynh Doan, University of British Columbia:
Pediatrics
Emergency Department
Point of Care Testing
Group A Strep

Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases