The Respiratory Protection Effectiveness Clinical Trial (ResPECT)
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 infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.
Respiratory Syncytial Viruses
Device: N95 Respirator
Device: Medical/surgical mask
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients|
- Protective Effects of N95 Respirators vs Medical Masks [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]To determine and analyze the magnitude of the change, if any, in incidence of laboratory confirmed influenza in healthcare practitioners wearing N95 respirators (2009 CDC guidelines) compared to medical masks (2007 guidelines).
- Incidence Determination of Influenza and Viral Respiratory Illness [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]To improve understanding about the burden of influenza and other viral respiratory illnesses among HCPs stationed in outpatient settings by evaluating the incidence of laboratory-confirmed influenza.
- Protective Effects [ Time Frame: 2010-2015 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]- To measure the incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in selected outpatient settings.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249625
|Contact: Trish M Perl, MD, MScemail@example.com|
|Contact: Jenna Losfirstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado Infectious Disease||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Ann-Christine Nyquist, MD 720-777-6981 Chris.Nyquist@childrenscolorado.org|
|Contact: Megan Brocato Megan.Brocato@childrenscolorado.org|
|Principal Investigator: Ann-Christine Nyquist, MD|
|Denver Health Medical Center||Recruiting|
|Denver, Colorado, United States, 80204|
|Contact: Connie Price, MD 303-436-7481 Connie.Price@dhha.org|
|Contact: Amy Irwin, MS, RN 303-436-4843 Amy.Irwin@dhha.org|
|Principal Investigator: Connie Price, MD|
|Denver Veteran's Administration Medical Center||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Mary Bessesen, MD email@example.com|
|Contact: Jill Adams, RN 303-399-8020 ext 2392 Jill.Adams@va.gov|
|Principal Investigator: Mary Bessesen, MD|
|United States, District of Columbia|
|Veterans Affairs Medical Center, Washington, DC||Recruiting|
|Washington, District of Columbia, United States, 20422|
|Contact: Cynthia Gibert, MD Cynthia.Gibert@va.gov|
|Contact: Dana Silver Dana.Silver@va.gov|
|Principal Investigator: Cynthia Gibert, MD|
|United States, Maryland|
|Johns Hopkins Health Sytstem||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Trish M Perl, MD 410-955-8384 firstname.lastname@example.org|
|Contact: Jenna Los 410-614-3506 email@example.com|
|Principal Investigator: Trish M Perl, MD|
|United States, New York|
|VA New York Harbor Healthcare System||Recruiting|
|New York City, New York, United States, 10010|
|Contact: Michael Simbekoff, MD 212-263-6481 mike.simberkoffMD@va.gov|
|Contact: Christine Reel-Brander, RN 718-836-6600 Christine.Reel-Brander@va.gov|
|Principal Investigator: Simberkoff Michael, MD|
|United States, Texas|
|Houston VA Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria Rodriguez-Barradas, MD Maria.Rodriguez-Barradas2@va.gov|
|Contact: Barbara Kertz 713-794-7224 firstname.lastname@example.org|
|Principal Investigator: Maria Rodriguez-Barradas, MD|
|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|