Clinical trial NCT03171350: Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Group A Streptococcal Infection
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 132
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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
timeFrame: 1 week
measure: 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
timeFrame: 1 week
measure: 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
timeFrame: 1 week
Secondary outcomes:
measure: 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
timeFrame: 1 week
measure: 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
timeFrame: 1 week
measure: 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
timeFrame: 1 week
measure: Ease of use as assessed by operator questionnaire.
timeFrame: 1 week
Other outcomes:
Locations:
city: Casey
country: Australia
facility: Ochre Health Medical Centre
state: Australian Capital Territory
city: Forbes
country: Australia
facility: Forbes Medical Centre
state: New South Wales
city: North Sydney
country: Australia
facility: Paratus Clinical Wyong Clinic
state: New South Wales
city: Tumbi Umbi
country: Australia
facility: Mingara Medical
state: New South Wales
city: Wamberal
country: Australia
facility: Wamberal Surgery
state: New South Wales
city: Wyoming
country: Australia
facility: Paratus Clinical Wyoming Clinic
state: New South Wales
city: Maroochydore
country: Australia
facility: USC Clinical Trials Centre
state: Queensland
city: Southport
country: Australia
facility: Griffith University Clinical Trial Unit
state: Queensland
Study officials:
affiliation: University of the Sunshine Coast Clinical Trials Centre
name: Glen Mulhall
role: PRINCIPAL_INVESTIGATOR
References: