Rapid POC GAS Diagnostics in the Paediatric ED

NCT ID: NCT04247243

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2024-04-04

Brief Summary

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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.

Detailed Description

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Conditions

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Streptococcal Pharyngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rapid testing

Abbott ID NOW Strep A testing.

Group Type EXPERIMENTAL

Rapid testing

Intervention Type DEVICE

Abbott ID NOW Strep A testing

Reference testing

Culture-based testing.

Group Type ACTIVE_COMPARATOR

Reference testing

Intervention Type DIAGNOSTIC_TEST

Culture-based testing

Interventions

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Rapid testing

Abbott ID NOW Strep A testing

Intervention Type DEVICE

Reference testing

Culture-based testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34380724 (View on PubMed)

Other Identifiers

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HAHSO POC GAS

Identifier Type: -

Identifier Source: org_study_id

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