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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

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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Recruitment Status : Withdrawn (Study was cancelled before enrollment for reasons not related to safety and performance.)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

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date January 16, 2019
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • 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
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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 ]
  • 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 ]
  • Ease of use as assessed by operator questionnaire [ Time Frame: 1 Week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Group A Streptococcal Infection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.

Interventions:
  • Diagnostic Test: ellume·lab Group A Streptococcus Test
  • Diagnostic Test: Bacterial Culture
  • Diagnostic Test: Polymerase Chain Reaction (PCR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
500
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03693495
Other Study ID Numbers  ICMJE E-GAS-NZ-1807
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ellume Pty Ltd
Study Sponsor  ICMJE Ellume Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barnaby H Montgomery Optimal Clinical Trials
PRS Account Ellume Pty Ltd
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP