Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03248960
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03248960
Study Brief:
Protocol Section:
NCT03248960