1716. Results of the Respiratory Protection Effectiveness Clinical Trial (ResPECT)
Session: Oral Abstract Session: Clinical Trials that May Change Your Practice
Saturday, October 6, 2018: 9:00 AM
Room: S 158

Results of the Respiratory Protection Effectiveness Clinical Trial (ResPECT)

Background:

Respiratory protection (RP) for health care personnel (HCP) is controversial and clinical studies are inconclusive about the effectiveness of N95 respirators (N95) and medical masks (MM) for protecting HCP from workplace viral respiratory infections and illnesses (VRII). 

Methods:

We conducted a cluster-randomized, investigator-blinded, multi-site effectiveness study comparing N95 to MM in geographically diverse, high exposure outpatient settings between 2011 and 2016.  Each year during VRII season, participants wore assigned devices when within 6 feet of patients with known or suspected respiratory illness.  Respiratory swabs were collected from symptomatic and asymptomatic participants. Diaries detailed VRII exposures, influenza vaccination, adherence to RP and hand hygiene, and manifestations of illness. The primary and secondary outcomes were the incidence of laboratory-confirmed influenza (LCI) using polymerase chain reaction (PCR) and hemagglutinin inhibition assays (HAI), and acute respiratory illness (ARI), influenza like illness (ILI), laboratory-confirmed respiratory illness (LCRI), and laboratory detected respiratory infection (LDRI) (Figure).  Intervention protective effects were estimated using unadjusted odds and incidence rate ratios.

Results:

5,180 HCP-seasons enrolled and randomized (2,243 to N95 and 2,446 to MM), with 4,689 (91%) completing the study.  In the intention-to-treat cohort (ITT), among participants in the N95 and MM groups respectively, 207 (8.2%) and 193 (7.2%) were diagnosed with LCI (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.93-1.40); 1,556 (61.9%) and 1711 (64.1%) were diagnosed with ARI (relative risk (RR) 0.99, CI 0.92-1.06); 128 (5.1%) and 166 (6.2%) were diagnosed with ILI (RR 0.87, CI 0.68-1.10), 371 (14.8%) and 417 (15.6%) were diagnosed with LCRI (RR 0.97, CI 0.84-1.12); and 679 (27.0%) and 745 (27.9%) were diagnosed with LDRI (RR 0.99, CI 0.89-1.09).  The adjusted ITT and per-protocol analyses yielded similar results.

 

Conclusion:

In this outpatient-based, cluster-randomized, controlled trial, neither N95 nor MM resulted in superior protection from LCI or VRII.

Figure: ResPECT Outcomes

Panel A: Influenza Incidence and Primary Outcomes        Panel B: Secondary Outcomes

Lewis Radonovich, MD, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Pittsburgh, PA, Michael S. Simberkoff, MD, FIDSA, VA New York Harbor Healthcare System, New York, NY, Mary Bessesen, MD, VA Eastern Colorado Healthcare System, Denver, CO, Alexandria C Brown, PhD, University of Massachusets Amherst, Amherst, MA, Derek Cummings, PhD, Department of Biology and Emerging Pathogens Institute;, University of Florida, Gainesville, FL, Charlotte Gaydos, DrPH, FIDSA, Division of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, MD, Jenna Los, MLA, Medicine, Johns Hopkins University, Baltimore, MD, Amanda Krosche, BS, College of Medicine, Weill Cornell Medicine, New York, NY, Cynthia Gibert, MD, MSc, FIDSA, Washington, DC, VAMC, Washington, DC, Geoffrey Gorse, MD, FIDSA, VA St. Louis Healthcare System, St. Louis, MO, Ann-Christine Nyquist, MD, MSPH, FPIDS, University of Colorado School of Medicine/Children’s Hospital Colorado, Aurora, CO, Nicholas Reich, PhD, Department of Biostatistics and Epidemiology, School of Public Health, University of Massachusetts Amherst, Amherst, MA, Maria Rodriguez-Barradas, MD, FIDSA, Department of Medicine, Michael E. DeBakey VA Medical Center, Houston, TX, Connie Price, MD, Infectious Diseases, University of Colorado School of Medicine/ Denver Health and Hospital, Denver, CO and Trish Perl, MD, MSc, FIDSA, FSHEA, Division of Infectious Diseases; Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX

Disclosures:

L. Radonovich, None

M. S. Simberkoff, None

M. Bessesen, None

A. C. Brown, None

D. Cummings, None

C. Gaydos, BioFire: Consultant , Consulting fee . Cepheid: Speaker's Bureau , Speaker honorarium . Becton Dickinson: Speaker's Bureau , Speaker honorarium .

J. Los, None

A. Krosche, None

C. Gibert, None

G. Gorse, None

A. C. Nyquist, None

N. Reich, None

M. Rodriguez-Barradas, None

C. Price, None

T. Perl, None

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