Clinical trial NCT03693495: Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Group A Streptococcal Infection
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 0
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 (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

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

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
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 a throat swab as compared to PCR
timeFrame: 1 Week
measure: Ease of use as assessed by operator questionnaire
timeFrame: 1 Week
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: Optimal Clinical Trials
state: Auckland
city: New Lynn
country: New Zealand
facility: Totara Clinical Research Ltd
state: Auckland
city: Papamoa
country: New Zealand
facility: Papamoa Pines Medical Centre
state: Tauranga
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
Study officials:
affiliation: Optimal Clinical Trials
name: Barnaby H Montgomery
role: PRINCIPAL_INVESTIGATOR
References: