The Respiratory Protection Effectiveness Clinical Trial

NCT01249625 | Completed Results DMC

• 1 other identifier: NA_00031266
• Study Type: interventional
• Target: 2,862
• Locations: 1 country
• Sites: 7

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.

Conditions

Influenza; Respiratory Syncytial Viruses; Paramyxoviridae Infections; Coronavirus; Rhinovirus

Keywords

Influenza; H1N1; Respiratory protection; N95 respirator; Medical mask; Personal protective equipment; Facial protective equipment; Pandemic planning

Outcome Measures

Primary Outcomes (1)

• Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events

  Number of influenza A and B events in healthcare practitioners wearing N95 respirators compared to medical masks.

  60 weeks

Secondary Outcomes (5)

• Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Influenza-like Illnesses

  60 weeks

• Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Confirmed Respiratory Illnesses

  60 weeks

• Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Detected Respiratory Infections

  60 weeks

• Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Acute Respiratory Illnesses

  60 weeks

• Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Laboratory Confirmed Illness

  60 weeks

Study Arms (2)

N95 Respirator

ACTIVE COMPARATOR

The investigators are comparing specific N95 respirator against specific medical masks.

Device: N95 Respirator

Medical/surgical mask

ACTIVE COMPARATOR

The investigators are comparing medical/surgical masks against the N95 respirator.

Device: Medical/surgical mask

Interventions

N95 Respirator DEVICE

Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period.

Also known as: 3M Corporation 1860, 1860S, and 1870 models, Kimberly Clark Technol Fluidshield Particulate Filter Respirator (PFR) 95-170, PFR 95-174

N95 Respirator

Medical/surgical mask DEVICE

Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period.

Also known as: Precept 15320, Kimberly Clark Technol Fluidshield 47107

Medical/surgical mask

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation
• Known to not tolerate wearing respiratory protective equipment for any period
• Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period
• Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study
• In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason
• Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
• Subject rotating in 2 different ResPECT study clinic sites /clusters during the 12-week study period.
• Subject works less than 75% of the intervention period in that clinic.
• Subject is a previous participant of the ResPECT Study, but does not consent for data from previous flu season(s) to be linked.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Disease Control and Prevention: collaborator
• US Department of Veterans Affairs: collaborator
• University of Massachusetts, Amherst: collaborator
• Denver Health and Hospital Authority: collaborator
• Children's Hospital Colorado: collaborator
• VA Eastern Colorado Health Care System: collaborator
• VA New York Harbor Healthcare System: collaborator
• Michael E. DeBakey VA Medical Center: collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator
• VA St. Louis Health Care System: collaborator

Study Sites (7)

Children's Hospital Colorado Infectious Disease

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Denver Veteran's Administration Medical Center

Denver, Colorado, 80220, United States

Location

Veterans Affairs Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Johns Hopkins Health Sytstem

Baltimore, Maryland, 21287, United States

Location

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

Houston VA Medical Center

Houston, Texas, 77030, United States

Location

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Related Links

• The National Institute for Occupational Safety and Health (NIOSH)

MeSH Terms

Conditions

Influenza, Human; Paramyxoviridae Infections; Coronavirus Infections

Interventions

N95 Respirators; Peak Expiratory Flow Rate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Mononegavirales Infections; Coronaviridae Infections; Nidovirales Infections

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Forced Expiratory Flow Rates; Pulmonary Ventilation; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Dr. Trish Perl
• Organization: University of Texas Southwestern

Trish.Perl@UTSouthwestern.edu

214-648-9022

Study Officials

• Trish M. Perl, MD

  UTSouthwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Lewis Radonovich, MD

  CDC-NIOSH

  PRINCIPAL INVESTIGATOR

• Derek Cummings, PhD

  University of Florida

  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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 25, 2019
• Results First Posted: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)