At a glance
ClinicalIndex Comparison Record- ✓Age 18–59 years at initial consent
- ✓Able to comprehend study requirements (score ≥70% on comprehension assessment, two attempts allowed)
- ✓Willing and able to comply with study procedures and available for required quarantine stay (2–5 days for donors, ~14 days for recipients)
- ✓[Donors only] Laboratory-confirmed influenza infection within past 48 hours at entry, with fever (≥100.2°F oral or self-reported) AND cough or sore throat
- ✕Female of childbearing potential with positive pregnancy test at admission or breastfeeding; for recipients, also planning pregnancy within 2 months
- ✕Respiratory disease (e.g., COPD, asthma, cystic fibrosis) requiring daily medications or any hospitalization/treatment for respiratory exacerbation in past 5 years
- ✕Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis/pericarditis as an adult
- ✕Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, Guillain-Barré syndrome)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)
In Brief
A clinical study evaluating Personal Protective Equipment (PPE) - Under High Air Hygiene, No Intervention - Under High Air Hygiene, and 2 other interventions for Influenza. Completed, enrolled 34 participants across 2 sites.
Detailed Summary
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
Study Details
Timeline
Interventions
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. High air hygiene is achieved by filtration and/or use of germicidal UV-C.
No intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C.
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. Low air hygiene is achieved with minimal ventilation.
No intervention Low air hygiene is achieved with minimal ventilation.