Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00756574
First received: September 19, 2008
Last updated: July 15, 2009
Last verified: July 2009

September 19, 2008
July 15, 2009
October 2008
April 2009   (final data collection date for primary outcome measure)
Laboratory-confirmed Influenza Infection [ Time Frame: one year ] [ Designated as safety issue: No ]
Laboratory-confirmed influenza infection [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00756574 on ClinicalTrials.gov Archive Site
  • 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 ]
In addition to laboratory-confirmed influenza, the investigators will assess influenza-like illness, work- related absenteeism, physician visits for respiratory illness, and lower respiratory infection or pneumonia. [ Time Frame: oney year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
  • Device: Surgical mask
    Surgical mask worn for patients with febrile respiratory illness
  • Device: N95 mask
    N95 mask worn for patients with febrile respiratory illness
  • Active Comparator: 1. Surgical
    surgical mask
    Intervention: Device: Surgical mask
  • Active Comparator: 2. N95 Respirator
    N95 respirator
    Intervention: Device: N95 mask
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00756574
6273-15-2008
Yes
Dr. Mark Loeb, Department of Pathology and Molecular Medicine, McMaster University, Hamilton ON
McMaster University
Health Canada
Principal Investigator: Mark Loeb, MD, MSc Hamilton Health Sciences - McMaster University
McMaster University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP