NCT00756574

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 21, 2009

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 19, 2008

Results QC Date

July 15, 2009

Last Update Submit

October 25, 2018

Conditions

Influenza

Keywords

N95Respiratormaskinfluenzaefficacy

Outcome Measures

Primary Outcomes (1)

  • Laboratory-confirmed Influenza Infection

    Laboratory confirmed influenza

    one year

Secondary Outcomes (3)

  • Physician Visits for Respiratory Illness

    one year

  • Influenza-like Illness

    Over entire study period

  • Absenteeism

    over study period

Study Arms (2)

1. Surgical

ACTIVE COMPARATOR

surgical mask

Device: Surgical mask

2. N95 Respirator

ACTIVE COMPARATOR

N95 respirator

Device: N95 mask

Interventions

Surgical maskDEVICE

Surgical mask worn for patients with febrile respiratory illness

1. Surgical
N95 maskDEVICE

N95 mask worn for patients with febrile respiratory illness

2. N95 Respirator

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses who work in emergency departments and medical units
  • Nurses expected to work full time (defined as \> 37 hours per week)

You may not qualify if:

  • Nurses who were not fit tested
  • Nurses who could not pass a fit test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Science

Hamilton, Ontario, Canada

Location

Related Publications (1)

  • 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. doi: 10.1001/jama.2009.1466. Epub 2009 Oct 1.

    PMID: 19797474DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesRespiratory Protective DevicesPersonal Protective EquipmentProtective DevicesSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Dr. Mark Loeb
Organization
McMaster University
loebm@mcmaster.ca
905-525-9140

Study Officials

  • Mark Loeb, MD, MSc

    Hamilton Health Sciences - McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

October 29, 2018

Results First Posted

August 21, 2009

Record last verified: 2018-10

Locations

CA(1)