Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03744832 |
| Other study ID # |
H18-02371 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2019 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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:
1. Age in years
2. Sex (Male or Female)
3. Triage acuity level using the Canadian Triage and Acuity Scale (CTAS)
4. Visit day of the week (weekday/weekend/holiday)
5. Length of stay (minutes) using date and time of arrival (registration/triage) and date
and time of discharge
6. McIsaac score (0-5)
7. 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.
