DMID 21-0041; Influenza CVD 59000

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.

Conditions

• Influenza

Interventions

BEHAVIORAL

Personal Protective Equipment (PPE) - Under High Air Hygiene

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.

BEHAVIORAL

No Intervention - Under High Air Hygiene

No intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C.

BEHAVIORAL

Personal Protective Equipment (PPE) - Under Low Air Hygiene

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.

BEHAVIORAL

No Intervention - Under Low Air Hygiene

No intervention Low air hygiene is achieved with minimal ventilation.

Sponsors & Collaborators

• University of Maryland, College Park

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Maryland, Baltimore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-20

Primary Completion

2024-04-17

Completion

2024-04-17

Countries

• United States

Study Locations