NCT03248960

Brief Summary

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture. The secondary aims are to: Validate the sensitivity and specificity of the iTreat Flu A+B 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). Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms. Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test. Evaluate the operators' satisfaction with the 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
381

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

July 27, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

August 10, 2017

Last Update Submit

January 30, 2018

Conditions

Influenza

Outcome Measures

Primary Outcomes (8)

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

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

    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.

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

    1 day

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

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

    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.

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

    1 day

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

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

    1 day

  • Of participants positive for influenza B by viral culture, 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 limits.

    1 day

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

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

    1 day

  • Of participants negative for influenza B by viral culture, 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 limits.

    1 day

Secondary Outcomes (11)

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

    1 day

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

    1 day

  • Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.

    1 day

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

    1 day

  • Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.

    1 day

  • +6 more secondary outcomes

Study Arms (1)

iTreat Flu A+B Test and ellume.lab Flu A+B Test

EXPERIMENTAL

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

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

Interventions

iTreat Flu A+B TestDIAGNOSTIC_TEST

The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.

iTreat Flu A+B Test and ellume.lab Flu A+B Test
ellume.lab Flu A+B TestDIAGNOSTIC_TEST

The ellume.lab Flu A+B Test is an 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. The ellume.lab Flu A+B Test generates a result within 10 minutes.

iTreat Flu A+B Test and ellume.lab Flu A+B Test
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.

iTreat Flu A+B Test and ellume.lab Flu A+B Test
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.

iTreat Flu A+B Test and ellume.lab Flu A+B Test

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and \<18 years: ellume.lab Flu A+B Test only; and
  • Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
  • Rhonorrhea or blocked nose; 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 \<1 year.
  • 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 have 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 Paticipants \<18 years of age unable to understand English and consent to participation of child.
  • Participants who have had prior exposure to iTreat Flu A+B Test.
  • participants who have been previously enrolled in the iE-FLU-AUS-1701 study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ochre Health Medical Centre Casey

Casey, Australian Capital Territory, 2913, Australia

Location

Paratus Clinical Blacktown Trial Clinic

Blacktown, New South Wales, 2148, Australia

Location

Paratus Clinical Kanwal Trial Clinic

Kanwal, New South Wales, 2559, Australia

Location

Coastal Family Health

Buddina, Queensland, 4575, Australia

Location

Morayfield Family Doctors

Morayfield, Queensland, 4506, Australia

Location

USC Health Clinics

Sippy Downs, Queensland, 4556, Australia

Location

Griffith University Clinical Trial Unit

Southport, Queensland, 4125, Australia

Location

Emeritus Research

Malvern East, Victoria, 3145, 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

August 10, 2017

First Posted

August 15, 2017

Study Start

July 27, 2017

Primary Completion

December 23, 2017

Study Completion

December 23, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

AU(8)