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The Respiratory Protection Effectiveness Clinical Trial (ResPECT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249625
First Posted: November 30, 2010
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centers for Disease Control and Prevention
Veterans Health Administration
University of Massachusetts, Amherst
Denver Health and Hospital Authority
Children's Hospital Colorado
VA Eastern Colorado Health Care System
VA New York Harbor Healthcare System
Michael Debakey Veterans Affairs Medical Center
Washington D.C. Veterans Affairs Medical Center
VA St. Louis Health Care System
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
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 ]
    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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1600
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249625


Locations
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, D.C., 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
Sponsors and Collaborators
Johns Hopkins University
Centers for Disease Control and Prevention
Veterans Health Administration
University of Massachusetts, Amherst
Denver Health and Hospital Authority
Children's Hospital Colorado
VA Eastern Colorado Health Care System
VA New York Harbor Healthcare System
Michael Debakey Veterans Affairs Medical Center
Washington D.C. Veterans Affairs Medical Center
VA St. Louis Health Care System
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:
U.S. Department of Health and Human Services: Food and Drug Administration (2005). Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. Rockville, MD: Food and Drug Administration.
Fisher LD, Dixon DO, Herson J, et al. (1990) Intention to treat in clinical trials. In: Peace KE (Ed.), Statistical issues in drug research and development (pp. 331-50). New York, NY: Marcel Dekker.
Hayes RJ and Moulton LH (2009) Cluster Randomised Trials. Chapman and Hall/CRC.
ICH Expert Working Group (1998). ICH Harmonised Tripartite Guideline, Statistical Principles for Clinical Trials E9, Current Step 4 version dated 5 February 1998. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf (last accessed 04 June 2017).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01249625     History of Changes
Other Study ID Numbers: NA_00031266
First Submitted: November 29, 2010
First Posted: November 30, 2010
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Paramyxoviridae Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Mononegavirales Infections