Pharyngitis AcuteNCT03744832
Point of Care Streptococcal Pharyngitis Testing
A study testing Alere i™ Strep A assay and Throat culture in people with Pharyngitis Acute, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Pharyngitis Acute
- What is being tested?
- Alere i™ Strep A assay and Throat culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteCanada
- Study dates
- 12 Aug 2019to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point of Care Group A Streptococcal Testing in a Pediatric Emergency Department: A Randomized Controlled Trial
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.
Read the detailed description
Purpose:
Molecular-based, nucleic acid amplification tests (NAATs), have been proposed as a diagnostic solution for streptococcal pharyngitis. Indeed, available data suggest that NAATs have similar performance to conventional culture testing, and point of care (POC) NAATs recently became commercially available. These bedside tests do not require operation by laboratory personnel and have been approved by Health Canada for use without the need for backup culture testing. This study seeks to compare the clinical outcomes of a POC NAAT approach with a conventional bacterial culture-based approach for children presenting to a Pediatric Emergency Department (PED) with suspected streptococcal pharyngitis. Results from this clinical trial will elicit critical information regarding the potential clinical benefit of implementing this new technology in the PED.
Hypothesis:
The investigators hypothesize that clinical outcomes (duration of illness, incidence of complications, absenteeism) and system utilization (PED length of stay, ancillary testing, return visits to hospital or community healthcare facility, appropriate antibiotic treatment) will improve with a POC NAAT diagnostic approach for suspected streptococcal pharyngitis.
Justification:
Determining the etiology of pharyngitis is necessary, both to minimize inappropriate antimicrobial therapy for viral infections, and to reduce the incidence of complications, duration of illness, and transmission of streptococcal infections, for which antibiotics are indicated. However, signs and symptoms of viral and streptococcal pharyngitis overlap significantly, and accurate differentiation based on history and clinical examination is difficult even for experienced clinicians. As a result, the Infectious Diseases Society of America (IDSA) currently recommends swabbing the throat and testing for streptococcal pharyngitis by culture, which is the current standard of practice at BC Children's Hospital (BCCH). However, while bacterial cultures are accurate and economical, they are often clinically impractical and cause delay in treatment due to the relatively long lag time (>48 hours) between collection of the specimen and final microbiological diagnosis. Available data suggest that new POC NAATs have similar performance to conventional culture testing with results available within 8 minutes. This could potentially improve clinical outcomes and reduce system utilization, but implementation would require significant task shifting, logistical support, and additional training. This study will provide an impact evaluation of this new technology in a PED, which is a necessary first step prior to implementation, in an effort to ultimately improve care for children and youth while minimizing costs to society.
Objectives:
The primary objective of this study is to compare POC NAAT testing with conventional throat culture testing (the current standard of care) for children and adolescents presenting to a PED for suspected streptococcal pharyngitis with regards to clinical management, symptom resolution, and resource utilization.
Demographic and Visit Characteristics:
- Age in years
- Sex (Male or Female)
- Triage acuity level using the Canadian Triage and Acuity Scale (CTAS)
- Visit day of the week (weekday/weekend/holiday)
- Length of stay (minutes) using date and time of arrival (registration/triage) and date and time of discharge
- McIsaac score (0-5)
- Disposition
Statistical Analysis:
Descriptive statistics will be used to summarize study population demographic and baseline characteristics. The Student t-test will be applied for continuous variables (mean time to symptom resolution, mean days off, etc.), and the chi-square test will be applied for categorical variables (proportion appropriately treated).
Quality Assurance:
Left over swabs from either study arm will be stored to subsequently culture or conduct NAAT testing for patients randomized to the interventional (POC testing) or standard (conventional culture) study arms, respectively. This alternate method testing will not be conducted until the end of the study, unless culture and sensitivity testing is required earlier for a patient that is randomized to the interventional POC study arm with a known severe beta-lactam allergy and/or does not respond to second-line therapy. The POC test performance will not be evaluated as part of this study as it has been determined to be at least equivalent to culture detection in the past.
Sample size estimation:
Using published literature on the effect of antibiotics on GAS pharyngitis, we estimate that the mean time to resolution in the POC group is 3 days (with a standard deviation of 2 days), and a minimally important difference in mean time to resolution between the groups being 1.5 days. Using 80% power at a significance level of 0.05, the required sample size is 28 subjects per group. With an estimated 30% positivity rate, and accounting for 10% of individuals lost to follow-up, the investigators will aim to recruit 100 subjects per group.
- Conditions
- Pharyngitis Acute
- Being tested
- Alere i™ Strep A assay, Throat culture
- Keywords
- Pediatrics, Emergency Department, Point of Care Testing, Group A Strep
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alere i™ Strep A assayDiagnostic 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.
Throat cultureDiagnostic test
Standard bacterial throat culture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Throat culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat resolution.
Mean time in half-days from ED discharge to sore throat resolution (POC vs. standard).
Measured: 7 days.
Secondary outcomes (8)
Fever resolution.
Mean time in half-days from ED discharge to fever resolution (axillary temperature; POC vs. standard).
Measured: 7 days.
Appropriate antibiotic utilization by patients/families.
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).
Measured: 7 days.
Calls averted.
Number of patient calls averted (POC vs. standard).
Measured: 7 days.
Parental Absenteeism.
Mean number of days away from work for a parent (measured by half day units; POC vs. standard).
Measured: 7 days.
Child Absenteeism
Mean number of days away from school/daycare for a child
Measured: 7 days
Healthcare return visits.
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).
Measured: 7 days.
Length of stay.
length of stay (LOS) will be calculated from time of registration/triage until discharge (POC vs. standard).
Measured: 7 days.
Ancillary testing.
May include, but is not limited to, a complete blood count, urinalysis, urine culture, blood, culture, or neck/chest radiographs (POC vs. standard).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start12 Aug 2019
- Primary completion23 Dec 2021
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharyngitis AcuteStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial.
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quynh Doan, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744832
- Sponsor's protocol ID
- H18-02371
- Status last verified
- May 2022
- First submitted
- 13 Nov 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
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.
PubMed 38498934
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Group A Streptococcal Testing in a Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03744832
- Acronym / sponsor ID
- H18-02371
- Conditions
- Pharyngitis Acute
- Keywords
- Pediatrics, Emergency Department, Point of Care Testing, Group A Strep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
Molecular-based, nucleic acid amplification tests (NAATs), have been proposed as a diagnostic solution for streptococcal pharyngitis. Indeed, available data suggest that NAATs have similar performance to conventional culture testing, and point of care (POC) NAATs recently became commercially available. These bedside tests do not require operation by laboratory personnel and have been approved by Health Canada for use without the need for backup culture testing. This study seeks to compare the clinical outcomes of a POC NAAT approach with a conventional bacterial culture-based approach for children presenting to a Pediatric Emergency Department (PED) with suspected streptococcal pharyngitis. Results from this clinical trial will elicit critical information regarding the potential clinical benefit of implementing this new technology in the PED.
Hypothesis:
The investigators hypothesize that clinical outcomes (duration of illness, incidence of complications, absenteeism) and system utilization (PED length of stay, ancillary testing, return visits to hospital or community healthcare facility, appropriate antibiotic treatment) will improve with a POC NAAT diagnostic approach for suspected streptococcal pharyngitis.
Justification:
Determining the etiology of pharyngitis is necessary, both to minimize inappropriate antimicrobial therapy for viral infections, and to reduce the incidence of complications, duration of illness, and transmission of streptococcal infections, for which antibiotics are indicated. However, signs and symptoms of viral and streptococcal pharyngitis overlap significantly, and accurate differentiation based on history and clinical examination is difficult even for experienced clinicians. As a result, the Infectious Diseases Society of America (IDSA) currently recommends swabbing the throat and testing for streptococcal pharyngitis by culture, which is the current standard of practice at BC Children's Hospital (BCCH). However, while bacterial cultures are accurate and economical, they are often clinically impractical and cause delay in treatment due to the relatively long lag time (>48 hours) between collection of the specimen and final microbiological diagnosis. Available data suggest that new POC NAATs have similar performance to conventional culture testing with results available within 8 minutes. This could potentially improve clinical outcomes and reduce system utilization, but implementation would require significant task shifting, logistical support, and additional training. This study will provide an impact evaluation of this new technology in a PED, which is a necessary first step prior to implementation, in an effort to ultimately improve care for children and youth while minimizing costs to society.
Objectives:
The primary objective of this study is to compare POC NAAT testing with conventional throat culture testing (the current standard of care) for children and adolescents presenting to a PED for suspected streptococcal pharyngitis with regards to clinical management, symptom resolution, and resource utilization.
Demographic and Visit Characteristics:
- Age in years
- Sex (Male or Female)
- Triage acuity level using the Canadian Triage and Acuity Scale (CTAS)
- Visit day of the week (weekday/weekend/holiday)
- Length of stay (minutes) using date and time of arrival (registration/triage) and date and time of discharge
- McIsaac score (0-5)
- Disposition
Statistical Analysis:
Descriptive statistics will be used to summarize study population demographic and baseline characteristics. The Student t-test will be applied for continuous variables (mean time to symptom resolution, mean days off, etc.), and the chi-square test will be applied for categorical variables (proportion appropriately treated).
Quality Assurance:
Left over swabs from either study arm will be stored to subsequently culture or conduct NAAT testing for patients randomized to the interventional (POC testing) or standard (conventional culture) study arms, respectively. This alternate method testing will not be conducted until the end of the study, unless culture and sensitivity testing is required earlier for a patient that is randomized to the interventional POC study arm with a known severe beta-lactam allergy and/or does not respond to second-line therapy. The POC test performance will not be evaluated as part of this study as it has been determined to be at least equivalent to culture detection in the past.
Sample size estimation:
Using published literature on the effect of antibiotics on GAS pharyngitis, we estimate that the mean time to resolution in the POC group is 3 days (with a standard deviation of 2 days), and a minimally important difference in mean time to resolution between the groups being 1.5 days. Using 80% power at a significance level of 0.05, the required sample size is 28 subjects per group. With an estimated 30% positivity rate, and accounting for 10% of individuals lost to follow-up, the investigators will aim to recruit 100 subjects per group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Point of Care Testing | Experimental | Diagnostic Test: Alere i™ Strep A assayPoint 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. |
| Standard Care | Active comparator | Diagnostic Test: Throat cultureConventional 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alere i™ Strep A assayPoint 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 | Point of Care Testing |
| Throat cultureStandard bacterial throat culture. | Diagnostic test | Standard Care |
Primary outcome
Sore throat resolution.
Time frame: 7 days.
Mean time in half-days from ED discharge to sore throat resolution (POC vs. standard).
8 secondary outcomes
Fever resolution.
Time frame: 7 days.
Appropriate antibiotic utilization by patients/families.
Time frame: 7 days.
Calls averted.
Time frame: 7 days.
Parental Absenteeism.
Time frame: 7 days.
Child Absenteeism
Time frame: 7 days
Healthcare return visits.
Time frame: 7 days.
Length of stay.
Time frame: 7 days.
Ancillary testing.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 38498934Gill 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alere i™ Strep A assay and Throat culture in people with Pharyngitis Acute, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sore throat resolution. (time frame: 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.