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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756574
First Posted: September 22, 2008
Last Update Posted: August 21, 2009
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.
Collaborator:
Health Canada
Information provided by:
McMaster University
Results First Submitted: July 15, 2009  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
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
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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
  Description
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 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   225   221   446 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.5  (10.6)   35.8  (10.6)   36.2  (10.6) 
Gender 
[Units: Participants]
     
Female   212   208   420 
Male   13   13   26 
Region of Enrollment 
[Units: Participants]
     
Canada   225   221   446 


  Outcome Measures
  Show All 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
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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
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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
e-mail: loebm@mcmaster.ca


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

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
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