Status:
COMPLETED
The Respiratory Protection Effectiveness Clinical Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Centers for Disease Control and Prevention
US Department of Veterans Affairs
Conditions:
Influenza
Respiratory Syncytial Viruses
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne in...
Detailed Description
Prevention strategies are key in limiting the transmission of respiratory viruses such as influenza. Among non-pharmacologic interventions, there is intense interest in the use of facial protective eq...
Eligibility Criteria
Inclusion
- Clinical site leadership has agreed to have one or more staff participate in the trial
- Subject meets the definition of "healthcare personnel"
- Subject able to read and sign informed consent
- Subject agrees to all requirements of the protocol, including fit testing and diary keeping
- Subject's age is 18 or greater
- Subject passes fit testing for one of the study supplied respirator models and agrees to use that model for the entire intervention period of the study (if in respirator arm).
Exclusion
- Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation
- Known to not tolerate wearing respiratory protective equipment for any period
- Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period
- Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study
- In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason
- Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
- Subject rotating in 2 different ResPECT study clinic sites /clusters during the 12-week study period.
- Subject works less than 75% of the intervention period in that clinic.
- Subject is a previous participant of the ResPECT Study, but does not consent for data from previous flu season(s) to be linked.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
2862 Patients enrolled
Trial Details
Trial ID
NCT01249625
Start Date
December 1 2010
End Date
March 1 2018
Last Update
April 25 2019
Active Locations (7)
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1
Children's Hospital Colorado Infectious Disease
Aurora, Colorado, United States, 80045
2
Denver Health Medical Center
Denver, Colorado, United States, 80204
3
Denver Veteran's Administration Medical Center
Denver, Colorado, United States, 80220
4
Veterans Affairs Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422