Streptococcal PharyngitisNCT04247243
Rapid POC GAS Diagnostics in the Paediatric ED
A study testing Rapid testing and Reference testing in people with Streptococcal Pharyngitis, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Streptococcal Pharyngitis
- What is being tested?
- Rapid testing and Reference testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2021to 4 Apr 2024
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all those presenting who have a throat swab ordered for GAS testing
Who cannot join
- those who took antibiotics effective against GAS within 72 h of ED presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group a Streptococcus: a Randomized Controlled Trial
Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.
- Conditions
- Streptococcal Pharyngitis
- Being tested
- Rapid testing, Reference testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid testingDevice
Abbott ID NOW Strep A testing
Reference testingDiagnostic test
Culture-based testing
| Study group | Role | What they receive |
|---|---|---|
| Rapid testing | Experimental | Abbott ID NOW Strep A testing. Receives: Device: Rapid testing |
| Reference testing | Active comparator | Culture-based testing. Receives: Diagnostic Test: Reference testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate antibiotic treatment
All participants will be contacted by phone to ascertain whether they took antibiotics for the treatment of streptococcal pharyngitis. 'Appropriate antibiotic treatment' is a dichotomous measure. If the participant's throat swab was positive for GAS and they took antibiotics, or if their throat swab was negative for GAS and they did NOT take antibiotics, antibiotic treatment will be deemed 'appropriate.' All other scenarios will be deemed not 'appropriate.'
Measured: 3-5 days post-enrolment
Secondary outcomes (9)
Time to resolution of symptoms
Measured: 3-5 and 7-10 days post-enrolment
Caregiver satisfaction with testing
Likert scale
Measured: 3-5 days post-enrolment
Number of days of missed school/daycare
Measured: 3-5 and 7-10 days post-enrolment
Number of days of missed work (caregiver)
Measured: 3-5 and 7-10 days post-enrolment
Number of healthcare visits for pharyngitis or sinopulmonary infections
Measured: 7 days post-enrolment
ED MD satisfaction with testing
The MD who clinically assessed the patient and who later discharged the patient home will be asked - if the participant was randomized to rapid testing - whether the testing was helpful. (The outcome will be ordinal on a Likert scale). If the participant was randomized to standard testing, they will be asked how helpful NOT having rapid testing was, again measured on the same Likert scale.
Measured: At enrolment
Number of household contacts subsequently diagnosed with GAS pharyngitis
Measured: 7-10 days post-enrolment
Proportion of point-of-care GAS tests that are uninterpretable
Measured: at enrolment
Time required to utilize point-of-care testing
Time from consent to discharge from the ED
Measured: at enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start4 Jan 2021
- Primary completion25 Mar 2024
- Study completion4 Apr 2024
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 Streptococcal PharyngitisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247243
- Sponsor's protocol ID
- HAHSO POC GAS
- Status last verified
- Mar 2024
- First submitted
- 20 Jan 2020
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Pernica JM, Smaill F, Kam AJ, Bartholomew A, Doan Q, Smieja M, Khan S, Sung M, Thabane L, Goldfarb DM. Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol. BMJ Open. 2021 Aug 11;11(8):e047271. doi: 10.1136/bmjopen-2020-047271.
PubMed 34380724
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group a Streptococcus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04247243
- Acronym / sponsor ID
- HAHSO POC GAS
- Conditions
- Streptococcal Pharyngitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 30 Jan 2020 (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.
Randomized trial evaluating effectiveness of rapid point-of-care molecular GAS diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to McMaster Children's Hospital Emergency Department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid testing | Experimental | Device: Rapid testingAbbott ID NOW Strep A testing. |
| Reference testing | Active comparator | Diagnostic Test: Reference testingCulture-based testing. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all those presenting who have a throat swab ordered for GAS testing
Key exclusion criteria (1 listed)
- those who took antibiotics effective against GAS within 72 h of ED presentation
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 |
|---|---|---|
| Rapid testingAbbott ID NOW Strep A testing | Device | Rapid testing |
| Reference testingCulture-based testing | Diagnostic test | Reference testing |
Primary outcome
Appropriate antibiotic treatment
Time frame: 3-5 days post-enrolment
All participants will be contacted by phone to ascertain whether they took antibiotics for the treatment of streptococcal pharyngitis. 'Appropriate antibiotic treatment' is a dichotomous measure. If the participant's throat swab was positive for GAS and they took antibiotics, or if their throat swab was negative for GAS and they did NOT take antibiotics, antibiotic treatment will be deemed 'appropriate.' All other scenarios will be deemed not 'appropriate.'
9 secondary outcomes
Time to resolution of symptoms
Time frame: 3-5 and 7-10 days post-enrolment
Caregiver satisfaction with testing
Time frame: 3-5 days post-enrolment
Number of days of missed school/daycare
Time frame: 3-5 and 7-10 days post-enrolment
Number of days of missed work (caregiver)
Time frame: 3-5 and 7-10 days post-enrolment
Number of healthcare visits for pharyngitis or sinopulmonary infections
Time frame: 7 days post-enrolment
ED MD satisfaction with testing
Time frame: At enrolment
Number of household contacts subsequently diagnosed with GAS pharyngitis
Time frame: 7-10 days post-enrolment
Proportion of point-of-care GAS tests that are uninterpretable
Time frame: at enrolment
Time required to utilize point-of-care testing
Time frame: at enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 34380724Pernica JM, Smaill F, Kam AJ, Bartholomew A, Doan Q, Smieja M, Khan S, Sung M, Thabane L, Goldfarb DM. Single-centre, open-label, randomised, trial to compare rapid molecular point-of-care streptococcal testing to standard laboratory-based testing for the management of streptococcal pharyngitis in children: study protocol. BMJ Open. 2021 Aug 11;11(8):e047271. doi: 10.1136/bmjopen-2020-047271.
- Individual participant dataSharing planned: Undecided
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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 Rapid testing and Reference testing in people with Streptococcal Pharyngitis, run by Hamilton Health Sciences Corporation 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: finished, as of the sponsor's last update on 3 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Appropriate antibiotic treatment (time frame: 3-5 days post-enrolment). 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 NCT04247243, 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 3 Oct 2024.