The Respiratory Protection Effectiveness Clinical Trial (ResPECT)
This study is currently recruiting participants.
Verified March 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborators:
Information provided by (Responsible Party):
Trish Perl, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01249625
First received: November 29, 2010
Last updated: March 28, 2012
Last verified: March 2012
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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:
|
|
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 16 week period of the study.
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. Subject must work at least 24 hours/week in the cluster/clinic in which they are recruited. Participants must spend at least 75% of the intervention period in that clinic.
Contacts and Locations
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 | |
| 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 | |
| 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 | |
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: | March 28, 2012 |
| 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:
|
Influenza, Human Paramyxoviridae Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Mononegavirales Infections |
ClinicalTrials.gov processed this record on May 22, 2013