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PPE and Air Hygiene for Flu Prevention (EMIT-2 Trial)
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and non-pregnant, non-breastfeeding females aged ≥18 and ≤49 years of age, at time of initial consent.
Within the past 72 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever of ≥100.2°F AND cough or sore throat, in the absence of an alternative cause.
Must not have
Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness.
Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find ways to reduce the spread of flu by limiting airborne transmission. #publichealth #flu
Who is the study for?
This trial is for healthy adults aged 18-49 who have recently contracted the flu. Participants must understand the study, stay in a research unit for about 5 days, and attend follow-ups. Pregnant or breastfeeding women, smokers, those with severe allergies to medicines, immunosuppressed individuals or those on certain medications cannot join.
What is being tested?
The EMIT-2 trial is testing how well Personal Protective Equipment (PPE) works under different air hygiene conditions to prevent airborne transmission of influenza. People will be randomly assigned to either use PPE or not under low and high air cleanliness settings.
What are the potential side effects?
Since this trial involves using PPE rather than medication, there are no direct side effects from drugs being tested. However, participants may experience discomfort or other issues related to wearing PPE such as skin irritation or difficulty breathing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 49 years old, not pregnant, and not breastfeeding.
Select...
I've had a fever over 100.2°F and a cough or sore throat in the last 3 days without another known cause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am immunosuppressed or take medication that affects my immune system.
Select...
I am a woman who can have children and am either breastfeeding or tested positive for pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Serological Confirmation
Symptomatic Confirmation
Viral Confirmation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention RecipientsExperimental Treatment2 Interventions
Intervention recipients are participants who do not have influenza and will use personal protective equipment.
Group II: DonorsExperimental Treatment2 Interventions
Donors are persons naturally infected with influenza.
Group III: Control RecipientsActive Control1 Intervention
Control recipients are participants who do not have influenza and will not be using personal protective equipment.
Find a Location
Who is running the clinical trial?
University of Maryland, College ParkOTHER
159 Previous Clinical Trials
46,263 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
380,914 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Control Recipients
- Group 2: Donors
- Group 3: Intervention Recipients