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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03693495




Registration number
NCT03693495
Ethics application status
Date submitted
1/10/2018
Date registered
3/10/2018
Date last updated
16/01/2019

Titles & IDs
Public title
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Scientific title
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
Secondary ID [1] 0 0
E-GAS-NZ-1807
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
Diagnosis / Prognosis - Bacterial Culture
Diagnosis / Prognosis - Polymerase Chain Reaction (PCR)

Experimental: ellume·lab Group A Streptococcus Test - ellume·lab Group A Streptococcus Test
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.


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 participants. The sample type used is a throat swab.

Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: 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.
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
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 a throat swab as compared to PCR
Timepoint [2] 0 0
1 Week
Secondary outcome [3] 0 0
Ease of use as assessed by operator questionnaire
Timepoint [3] 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 (or fossae);

- Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy

- = 14 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

- 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

- Prior enrollment in this clinical validation study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2019
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Tauranga
Country [3] 0 0
New Zealand
State/province [3] 0 0
Rotorua

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/ct2/show/NCT03693495
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barnaby H Montgomery
Address 0 0
Optimal Clinical Trials
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/ct2/show/NCT03693495