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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756574
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : August 21, 2009
Last Update Posted : August 21, 2009
Health Canada
Information provided by:
McMaster University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Device: Surgical mask
Device: N95 mask

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
1. Surgical surgical mask
2. N95 Respirator N95 respirator

Participant Flow:   Overall Study
    1. Surgical   2. N95 Respirator
STARTED   225   221 
COMPLETED   212   210 
NOT COMPLETED   13   11 
Withdrawal by Subject                9                7 
Lost to Follow-up                4                4 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
1. Surgical surgical mask
2. N95 Respirator N95 respirator
Total Total of all reporting groups

Baseline Measures
   1. Surgical   2. N95 Respirator   Total 
Overall Participants Analyzed 
[Units: Participants]
 225   221   446 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   225   221   446 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 36.5  (10.6)   35.8  (10.6)   36.2  (10.6) 
[Units: Participants]
Female   212   208   420 
Male   13   13   26 
Region of Enrollment 
[Units: Participants]
Canada   225   221   446 

  Outcome Measures

1.  Primary:   Laboratory-confirmed Influenza Infection   [ Time Frame: one year ]

2.  Secondary:   Physician Visits for Respiratory Illness   [ Time Frame: one year ]

3.  Secondary:   Influenza-like Illness   [ Time Frame: Over entire study period ]

4.  Secondary:   Absenteeism   [ Time Frame: over study period ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Mark Loeb
Organization: McMaster University
phone: 905-525-9140 ext 26066

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Dr. Mark Loeb, Department of Pathology and Molecular Medicine, McMaster University, Hamilton ON Identifier: NCT00756574     History of Changes
Other Study ID Numbers: 6273-15-2008
First Submitted: September 19, 2008
First Posted: September 22, 2008
Results First Submitted: July 15, 2009
Results First Posted: August 21, 2009
Last Update Posted: August 21, 2009