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
Results First Received: July 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Interventions: Device: Surgical mask
Device: N95 mask

  Participant Flow
  Hide Participant Flow

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
No text entered.

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
  Hide 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.
No text entered.

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  
Number of Participants  
[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


  More Information
  Hide 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Mark Loeb
Organization: McMaster University
phone: 905-525-9140 ext 26066
e-mail: loebm@mcmaster.ca


No publications provided by McMaster University

Publications automatically indexed to this study:

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