- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00756574
Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza
October 25, 2018 updated by: McMaster University
A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting.
The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season.
The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95.
The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
447
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- Hamilton Health Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nurses who work in emergency departments and medical units
- Nurses expected to work full time (defined as > 37 hours per week)
Exclusion Criteria:
- Nurses who were not fit tested
- Nurses who could not pass a fit test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1. Surgical
surgical mask
|
Surgical mask worn for patients with febrile respiratory illness
|
Active Comparator: 2. N95 Respirator
N95 respirator
|
N95 mask worn for patients with febrile respiratory illness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratory-confirmed Influenza Infection
Time Frame: one year
|
Laboratory confirmed influenza
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Visits for Respiratory Illness
Time Frame: one year
|
visit to primary care MD
|
one year
|
Influenza-like Illness
Time Frame: Over entire study period
|
Cough and fever
|
Over entire study period
|
Absenteeism
Time Frame: over study period
|
Absent from work because of flu-like illness
|
over study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Loeb, MD, MSc, Hamilton Health Sciences - McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
September 19, 2008
First Submitted That Met QC Criteria
September 19, 2008
First Posted (Estimate)
September 22, 2008
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6273-15-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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