NCT03595358

Brief Summary

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to reverse transcriptase polymerase chain reaction (RT-PCR) Secondary aims are to: Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

July 11, 2018

Last Update Submit

June 12, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (8)

  • Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.

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

    1 day

  • Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by ellume.lab Flu A+B Test.

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

    1 day

  • Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.

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

    1 day

  • Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by ellume.lab Flu A+B Test.

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

    1 day

  • Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.

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

    1 day

  • Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by ellume.lab Flu A+B Test.

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

    1 day

  • Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.

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

    1 day

  • Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by ellume.lab Flu A+B Test.

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

    1 day

Secondary Outcomes (11)

  • Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.

    1 day

  • Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.

    1day

  • Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.

    1 day

  • Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.

    1 day

  • Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test.

    1 day

  • +6 more secondary outcomes

Study Arms (1)

Arm

EXPERIMENTAL

Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.

Diagnostic Test: Ellume Home Flu TestDiagnostic Test: ellume.lab Flu A+B TestDiagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Diagnostic Test: Viral culture

Interventions

Ellume Home Flu TestDIAGNOSTIC_TEST

The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.

Arm
ellume.lab Flu A+B TestDIAGNOSTIC_TEST

The ellume.lab Flu A+B Test is a rapid in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples.

Arm
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)DIAGNOSTIC_TEST

Reverse Transcriptase Polymerase Chain Reaction (RT\_PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.

Arm
Viral cultureDIAGNOSTIC_TEST

Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.

Arm

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants aged ≥ 2 years; and
  • 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
  • Rhinorrhea; and
  • ≤ 72 hours from onset of ILI symptoms; and
  • Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
  • Participant (or parent/legal guardian) able to read and write in English.

You may not qualify if:

  • Participants aged \< 2 years.
  • Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days;
  • Participants who have been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
  • Participants who have had a nose bleed within the past 30 days;
  • Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
  • Participants currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent.
  • Participants previously enrolled in IE-FLU-AUS-1801;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paratus Clinical Kanwal Trial Clinic

Kanwal, New South Wales, 2559, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 23, 2018

Study Start

August 31, 2018

Primary Completion

November 16, 2018

Study Completion

November 16, 2018

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

AU(1)