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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03171350