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Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03171350
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ellume Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Group A Streptococcal Infection Diagnostic Test: ellume.lab Group A Streptococcus Test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018


Arm Intervention/treatment
Experimental: ellume.lab Group A Streptococcus Test
ellume.lab Group A Streptococcus Test
Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 1 week ]
  2. 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 [ Time Frame: 1 week ]
  3. 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 [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 week ]
  2. 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 [ Time Frame: 1 week ]
  3. 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 [ Time Frame: 1 week ]
  4. Ease of use as assessed by operator questionnaire. [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171350


Locations
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Australia, Australian Capital Territory
Ochre Health Medical Centre
Casey, Australian Capital Territory, Australia, 2913
Australia, New South Wales
Forbes Medical Centre
Forbes, New South Wales, Australia, 2871
Paratus Clinical Wyong Clinic
North Sydney, New South Wales, Australia, 2060
Mingara Medical
Tumbi Umbi, New South Wales, Australia, 2261
Wamberal Surgery
Wamberal, New South Wales, Australia, 2260
Paratus Clinical Wyoming Clinic
Wyoming, New South Wales, Australia, 2250
Australia, Queensland
USC Clinical Trials Centre
Maroochydore, Queensland, Australia, 4558
Griffith University Clinical Trial Unit
Southport, Queensland, Australia, 4215
Sponsors and Collaborators
Ellume Pty Ltd
Investigators
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Principal Investigator: Glen Mulhall University of the Sunshine Coast Clinical Trials Centre

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Responsible Party: Ellume Pty Ltd
ClinicalTrials.gov Identifier: NCT03171350     History of Changes
Other Study ID Numbers: E-GAS-AUS-1701
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pharyngitis
Streptococcal Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections