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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03171350




Registration number
NCT03171350
Ethics application status
Date submitted
28/05/2017
Date registered
31/05/2017
Date last updated
24/09/2018

Titles & IDs
Public title
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Scientific title
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
Secondary ID [1] 0 0
E-GAS-AUS-1701
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Group A Streptococcal Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - ellume.lab Group A Streptococcus Test

Experimental: ellume.lab Group A Streptococcus Test - ellume.lab Group A Streptococcus Test


Diagnosis / Prognosis: 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Timepoint [1] 0 0
1 week
Primary outcome [2] 0 0
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Timepoint [2] 0 0
1 week
Primary outcome [3] 0 0
The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from bacterial culture
Timepoint [3] 0 0
1 week
Secondary outcome [1] 0 0
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using throat swab as compared to PCR
Timepoint [2] 0 0
1 week
Secondary outcome [3] 0 0
The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from PCR
Timepoint [3] 0 0
1 week
Secondary outcome [4] 0 0
Ease of use as assessed by operator questionnaire.
Timepoint [4] 0 0
1 week

Eligibility
Key inclusion criteria
* Male and female participants aged 3 years of age or older
* Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:

* Acute onset of sore throat;
* Fever = 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever = 37.8° C or feeling feverish within 24 hours of presentation and;
* At least one of the following:

* Red and swollen/inflamed tonsils;
* Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
* = 5 days from onset of signs and symptoms of pharyngitis
* Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
* Participants =18 years of age capable and willing to give informed consent
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants < 3 years of age
* Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
* Participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers
* Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
* Participants 18 years of age or older unable to understand English and consent to participation
* Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/08/2018
Sample size
Target
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Ochre Health Medical Centre - Casey
Recruitment hospital [2] 0 0
Forbes Medical Centre - Forbes
Recruitment hospital [3] 0 0
Paratus Clinical Wyong Clinic - North Sydney
Recruitment hospital [4] 0 0
Mingara Medical - Tumbi Umbi
Recruitment hospital [5] 0 0
Wamberal Surgery - Wamberal
Recruitment hospital [6] 0 0
Paratus Clinical Wyoming Clinic - Wyoming
Recruitment hospital [7] 0 0
USC Clinical Trials Centre - Maroochydore
Recruitment hospital [8] 0 0
Griffith University Clinical Trial Unit - Southport
Recruitment postcode(s) [1] 0 0
2913 - Casey
Recruitment postcode(s) [2] 0 0
2871 - Forbes
Recruitment postcode(s) [3] 0 0
2060 - North Sydney
Recruitment postcode(s) [4] 0 0
2261 - Tumbi Umbi
Recruitment postcode(s) [5] 0 0
2260 - Wamberal
Recruitment postcode(s) [6] 0 0
2250 - Wyoming
Recruitment postcode(s) [7] 0 0
4558 - Maroochydore
Recruitment postcode(s) [8] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ellume Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03171350
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glen Mulhall
Address 0 0
University of the Sunshine Coast Clinical Trials Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03171350