Clinical Trial: The Respiratory Protection Effectiveness Clinical Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients

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 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.

Detailed Summary:

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 equipment (FPE) - surgical masks or N95 respirators - as a key component of personal protective equipment (PPE) when faced with seasonal influenza or other respiratory illness. However, their relative protective effect is unknown, especially in the outpatient setting. To plan for future epidemics and best manage limited supplies of FPE, evidence is needed to guide planning activities and policy makers. This project aims to answer a key question about PPE use: How do respirators (N95s) protect HCWs in the outpatient setting against influenza, influenza-like illness (ILI), acute respiratory illness (ARI) and other respiratory illnesses, as compared to surgical masks? This study will have the following outcomes:

  • An analysis to determine the most effective facial protective equipment to use to prevent disease transmission in the outpatient setting during a seasonal influenza outbreak, epidemic or pandemic event.
  • An analysis of the incidence of organism-specific rates of respiratory viral infections in the outpatient setting during influenza season.
  • An assessment of the incidence rate of organism-specific respiratory viral infections in the outpatient setting.

This is an approximately 16-18 week study. The investigators will initiate the study when viral surveillance data indicates that influenza season has begun. Recruitment will be accomplished through informational meetings with clinic staff. Participants will have blood drawn before week 1 and after the end of the active portion of the study to assess seroconversion over t
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • 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 CDC guidelines) compared to medical masks (2007 guidelines).
  • Incidence Determination of Influenza and Viral Respiratory Illness [ Time Frame: 2010-2015 ]
    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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: November 29, 2010
Date Started: December 2010
Date Completion: December 2017
Last Updated: July 29, 2016
Last Verified: July 2016