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Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants 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: NCT03693495
Recruitment Status : Withdrawn (Study was cancelled before enrollment for reasons not related to safety and performance.)
First Posted : October 3, 2018
Last Update Posted : January 16, 2019
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 Diagnostic Test: Bacterial Culture Diagnostic Test: Polymerase Chain Reaction (PCR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
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.

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 participants. The sample type used is a throat swab.

Diagnostic Test: 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.

Diagnostic Test: 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.




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 ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals

  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 ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals


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 ]
    Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals

  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 PCR [ Time Frame: 1 Week ]
    Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals

  3. Ease of use as assessed by operator questionnaire [ Time Frame: 1 Week ]
    The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).



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 (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

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): NCT03693495


Locations
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New Zealand
Optimal Clinical Trials
Grafton, Auckland, New Zealand, 1010
Totara Clinical Research Ltd
New Lynn, Auckland, New Zealand, 0600
Papamoa Pines Medical Centre
Papamoa, Tauranga, New Zealand, 3118
Lakeland Clinical Trials
Rotorua, New Zealand, 3010
Sponsors and Collaborators
Ellume Pty Ltd
Investigators
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Principal Investigator: Barnaby H Montgomery Optimal Clinical Trials
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Responsible Party: Ellume Pty Ltd
ClinicalTrials.gov Identifier: NCT03693495    
Other Study ID Numbers: E-GAS-NZ-1807
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
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
Additional relevant MeSH terms:
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Pharyngitis
Streptococcal Infections
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses