Trials / Withdrawn
WithdrawnNCT03693495
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
A Prospective Multi-Centre Study of the Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (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 participants. The sample type used is a throat swab. |
| DIAGNOSTIC_TEST | Bacterial Culture | Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test. |
| DIAGNOSTIC_TEST | Polymerase Chain Reaction (PCR) | Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected. |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
- First posted
- 2018-10-03
- Last updated
- 2019-01-16
Locations
4 sites across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT03693495. Inclusion in this directory is not an endorsement.