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

This study has been completed.

Study NCT00756574 Information provided by McMaster University

First Received on September 19, 2008. Last Updated on July 15, 2009 History of Changes

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

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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
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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

	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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Reporting Groups

	Description
1. Surgical	surgical mask
2. N95 Respirator	N95 respirator

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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Absenteeism [ Time Frame: over study period ]

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Serious Adverse Events

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Other Adverse Events

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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.

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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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:

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