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OpenTrials
Completed

NCT Number: NCT04247243

Rapid POC GAS Diagnostics in the Paediatric ED

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.

Completed

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Key information

Conditions

Streptococcal Pharyngitis

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all those presenting who have a throat swab ordered for GAS testing

Exclusion criteria

  • those who took antibiotics effective against GAS within 72 h of ED presentation

Treatment and study plan

Rapid testing

Device

Abbott ID NOW Strep A testing

Reference testing

Diagnostic Test

Culture-based testing

Primary outcomes

  1. 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.'

Secondary outcomes

  1. Time to resolution of symptoms

    Time frame: 3-5 and 7-10 days post-enrolment

  2. Caregiver satisfaction with testing

    Time frame: 3-5 days post-enrolment

    Likert scale

  3. Number of days of missed school/daycare

    Time frame: 3-5 and 7-10 days post-enrolment

  4. Number of days of missed work (caregiver)

    Time frame: 3-5 and 7-10 days post-enrolment

  5. Number of healthcare visits for pharyngitis or sinopulmonary infections

    Time frame: 7 days post-enrolment

  6. ED MD satisfaction with testing

    Time frame: At enrolment

    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.

  7. Number of household contacts subsequently diagnosed with GAS pharyngitis

    Time frame: 7-10 days post-enrolment

  8. Proportion of point-of-care GAS tests that are uninterpretable

    Time frame: at enrolment

  9. Time required to utilize point-of-care testing

    Time frame: at enrolment

    Time from consent to discharge from the ED

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Streamlining Care Delivery in the Paediatric Emergency Department Using Rapid Point-of-care Diagnostics for Group a Streptococcus: a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2020
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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