Who is sponsoring NCT03171350?

NCT03171350 is sponsored by Ellume Pty Ltd.

What drugs are being tested in NCT03171350?

Interventions in NCT03171350: ellume.lab Group A Streptococcus Test.

What condition does NCT03171350 study?

NCT03171350 studies Group A Streptococcal Infection.

Is NCT03171350 still recruiting?

NCT03171350 is currently completed. Last updated 24 September 2018.

Last reviewed 2018-09-24 · How we verify

NCT03171350

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.

Completed NA Last updated 24 September 2018

What this trial tests

NA trial testing ellume.lab Group A Streptococcus Test in Group A Streptococcal Infection in 132 participants. Completed in 15 August 2018.

Timeline

24 May 2017

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	Ellume Pty Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	132
Start date	24 May 2017
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	8 locations across Australia

Drugs / interventions tested

ellume.lab Group A Streptococcus Test

Conditions studied

Group A Streptococcal Infection — all drugs for Group A Streptococcal Infection →

Sponsor

Ellume Pty Ltd

Who can join

3 and older, any sex, with Group A Streptococcal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Ellume Pty Ltd trials

Trials by the same sponsor.

NCT03595358 — Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymera · NA · completed
NCT03248960 — Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymeras · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03171350 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ellume Pty Ltd
Last refreshed: 24 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03171350.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing