Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza - Full Text View

Sponsor:	McMaster University
Collaborator:	Health Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00756574

Purpose

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.

Condition	Intervention
Influenza	Device: Surgical mask Device: N95 mask

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Laboratory-confirmed Influenza Infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physician Visits for Respiratory Illness [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Influenza-like Illness [ Time Frame: Over entire study period ] [ Designated as safety issue: No ]
Absenteeism [ Time Frame: over study period ] [ Designated as safety issue: No ]

Enrollment:	447
Study Start Date:	October 2008
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1. Surgical surgical mask	Device: Surgical mask Surgical mask worn for patients with febrile respiratory illness
Active Comparator: 2. N95 Respirator N95 respirator	Device: N95 mask N95 mask worn for patients with febrile respiratory illness

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756574

Locations

Canada, Ontario
Hamilton Health Science
Hamilton, Ontario, Canada

Sponsors and Collaborators

McMaster University

Health Canada

Investigators

Principal Investigator:

Mark Loeb, MD, MSc

Hamilton Health Sciences - McMaster University

More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Loeb M, Dafoe N, Mahony J, John M, Sarabia A, Glavin V, Webby R, Smieja M, Earn DJ, Chong S, Webb A, Walter SD. Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial. JAMA. 2009 Nov 4;302(17):1865-71. Epub 2009 Oct 1.

Responsible Party:	Dr. Mark Loeb, Department of Pathology and Molecular Medicine, McMaster University, Hamilton ON
ClinicalTrials.gov Identifier:	NCT00756574 History of Changes
Other Study ID Numbers:	6273-15-2008
Study First Received:	September 19, 2008
Results First Received:	July 15, 2009
Last Updated:	July 15, 2009
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

N95
Respirator
mask
influenza
efficacy

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 07, 2012