N/A
N=2,862
The Respiratory Protection Effectiveness Clinical Trial
Influenza · Respiratory Syncytial Viruses · Paramyxoviridae Infections · Coronavirus · Rhinovirus
Bottom Line
View on ClinicalTrials.gov: NCT01249625 ↗Enrolled (actual)
2,862
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events — 222; 204 number of influenza A and B events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- N95 Respirator (Device); Medical/surgical mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Protective Effects of N95 Respirators vs Medical Masks (MM) as Assessed by Number of Influenza A and B Events |
222; 204 | — |
| SECONDARY Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Influenza-like Illnesses |
128; 166 | — |
| SECONDARY Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Confirmed Respiratory Illnesses |
371; 417 | — |
| SECONDARY Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Lab Detected Respiratory Infections |
679; 745 | — |
| SECONDARY Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Acute Respiratory Illnesses |
1556; 1711 | — |
| SECONDARY Protective Effects of N95 Respirators vs Medical Masks as Assessed by Number of Laboratory Confirmed Illness |
207; 193 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01249625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.