Trials / Completed
CompletedNCT03171350
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
A Prospective Multi-Centre Study of the Performance of the Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Ellume Pty Ltd · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ellume.lab Group A Streptococcus Test | ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic patients. The sample type used is a throat swab. |
Timeline
- Start date
- 2017-05-24
- Primary completion
- 2018-08-15
- Completion
- 2018-08-15
- First posted
- 2017-05-31
- Last updated
- 2018-09-24
Locations
8 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03171350. Inclusion in this directory is not an endorsement.