Trial record 2 of 3 for:    Open Studies | "Coronavirus Infections"

The Respiratory Protection Effectiveness Clinical Trial (ResPECT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01249625
First received: November 29, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Influenza
Respiratory Syncytial Viruses
Paramyxoviridae Infections
Coronavirus
Rhinovirus
Device: N95 Respirator
Device: Medical/surgical mask

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1600
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)
Arms Assigned Interventions
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.
Other Names:
  • 3M Corporation 1860, 1860S, and 1870 models
  • Kimberly Clark Technol Fluidshield PFR95-170, PFR95-174
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.
Other Names:
  • Precept 15320
  • Kimberly Clark Technol Fluidshield 47107

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Clinical site leadership has agreed to have one or more staff participate in the trial
  • (2) Subject meets the definition of "healthcare personnel"
  • (3) Subject able to read and sign informed consent
  • (4) Subject agrees to all requirements of the protocol, including fit testing and diary keeping
  • (5) Subject's age is 18 or greater
  • (6) 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 Criteria:

  • (1) Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation
  • (2) Known to not tolerate wearing respiratory protective equipment for any period
  • (3) Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period
  • (4) Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study
  • (5) In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason
  • (6) Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
  • (7) Subject rotating in 2 different ResPECT study clinic sites /clusters during the 12-week study period.
  • (8) Subject works less than 24 hours/week in the cluster/clinic in which they are recruited.
  • (9) Subject works less than 75% of the intervention period in that clinic.
  • (10) Subject is a previous participant of the ResPECT Study, but does not consent for data from previous flu season(s) to be linked.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249625

Contacts
Contact: Trish M Perl, MD, MSc 410-502-9617 tperl@jhmi.edu
Contact: Jenna Los 410-614-3506 jlos1@jhmi.edu

Locations
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       mary.bessesen@va.gov   
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    tperl@jhmi.edu   
Contact: Jenna Los    410-614-3506    jlos1@jhmi.edu   
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    barbara.kertz@va.gov   
Principal Investigator: Maria Rodriguez-Barradas, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trish Perl, Trish M. Perl, MD, MSc, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01249625     History of Changes
Other Study ID Numbers: NA_00031266
Study First Received: November 29, 2010
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Influenza
H1N1
Respiratory protection
N95 respirator
Medical mask
Personal protective equipment
Facial protective equipment
Pandemic planning

Additional relevant MeSH terms:
Coronavirus Infections
Influenza, Human
Paramyxoviridae Infections
Respirovirus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on August 26, 2014