The Respiratory Protection Effectiveness Clinical Trial (ResPECT)
|ClinicalTrials.gov Identifier: NCT01249625|
Recruitment Status : Active, not recruiting
First Posted : November 30, 2010
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Influenza Respiratory Syncytial Viruses Paramyxoviridae Infections Coronavirus Rhinovirus||Device: N95 Respirator Device: Medical/surgical mask||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Active Comparator: N95 Respirator
The investigators are comparing the 3M 1860 N95 respirator against the Precept 15320 medical mask.
Device: N95 Respirator
Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period.
Active Comparator: Medical/surgical mask
The investigators are comparing the Precept 15320 medical/surgical mask against the 3M 1860 N95 respirator.
Device: Medical/surgical mask
Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period.
- Protective Effects of N95 Respirators vs Medical Masks [ Time Frame: 2010-2015 ]To determine and analyze the magnitude of the change, if any, in incidence of laboratory confirmed influenza in healthcare practitioners wearing N95 respirators (2009 Centers for Disease Control and Prevention (CDC) guidelines) compared to medical masks (2007 guidelines).
- Incidence Determination of Influenza and Viral Respiratory Illness [ Time Frame: 2010-2015 ]Incidence of laboratory-confirmed influenza.
- Protective Effects [ Time Frame: 2010-2015 ]
- To determine and analyze the magnitude of the change, if any, in incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in HCPs wearing N95 respirators compared to medical masks.
- To examine the relationship between incidence and possible risk factors, including compliance, attitudes and opinions of HCPs and workplace exposures.
- Incidence determination [ Time Frame: 2010-2015 ]- To measure the incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in selected outpatient settings.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249625
|United States, Colorado|
|Children's Hospital Colorado Infectious Disease|
|Aurora, Colorado, United States, 80045|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Denver Veteran's Administration Medical Center|
|Denver, Colorado, United States, 80220|
|United States, District of Columbia|
|Veterans Affairs Medical Center, Washington, DC|
|Washington, District of Columbia, United States, 20422|
|United States, Maryland|
|Johns Hopkins Health Sytstem|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|VA New York Harbor Healthcare System|
|New York, New York, United States, 10010|
|United States, Texas|
|Houston VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Trish M. Perl, MD||Johns Hopkins University School of Medicine/Johns Hopkins Hospital|
|Principal Investigator:||Lewis Radonovich, MD||North Georgia/South Florida VA|
|Study Director:||Derek Cummings, PhD||Johns Hopkins University|
|Study Director:||Michael Simberkoff, MD||New York Harbor Healthcare System VA|
|Study Director:||Connie S Price, MD||University of Colorado (Denver Health)|
|Study Director:||Charlotte Gaydos, PhD||Johns Hopkins University|
|Study Director:||Nicholas Reich, PhD||University of Massachusetts, Amherst|