Trial Outcomes & Findings for Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza (NCT NCT00756574)

NCT ID: NCT00756574

Last Updated: 2018-10-29

Results Overview

Laboratory confirmed influenza

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 447 participants
• Primary outcome timeframe: one year
• Results posted on: 2018-10-29

Participant Flow

Participant milestones

Measure	1. Surgical surgical mask	2. N95 Respirator N95 respirator
Overall Study STARTED	225	221
Overall Study COMPLETED	212	210
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Measure	1. Surgical surgical mask	2. N95 Respirator N95 respirator
Overall Study Withdrawal by Subject	9	7
Overall Study Lost to Follow-up	4	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	1. Surgical n=225 Participants surgical mask	2. N95 Respirator n=221 Participants N95 respirator	Total n=446 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	225 Participants n=5 Participants	221 Participants n=7 Participants	446 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.5 years STANDARD_DEVIATION 10.6 • n=5 Participants	35.8 years STANDARD_DEVIATION 10.6 • n=7 Participants	36.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants	208 Participants n=7 Participants	420 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Canada	225 participants n=5 Participants	221 participants n=7 Participants	446 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Laboratory confirmed influenza

Outcome measures

Measure	1. Surgical n=212 Participants surgical mask	2. N95 Respirator n=210 Participants N95 respirator
Laboratory-confirmed Influenza Infection	50 participants	48 participants

SECONDARY outcome

Timeframe: one year

visit to primary care MD

Outcome measures

Measure	1. Surgical n=212 Participants surgical mask	2. N95 Respirator n=210 Participants N95 respirator
Physician Visits for Respiratory Illness	13 participants	13 participants

SECONDARY outcome

Timeframe: Over entire study period

Cough and fever

Outcome measures

Measure	1. Surgical n=212 Participants surgical mask	2. N95 Respirator n=210 Participants N95 respirator
Influenza-like Illness	9 participants	2 participants

SECONDARY outcome

Timeframe: over study period

Absent from work because of flu-like illness

Outcome measures

Measure	1. Surgical n=212 Participants surgical mask	2. N95 Respirator n=210 Participants N95 respirator
Absenteeism	42 participants	39 participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark Loeb

McMaster University

Phone: 905-525-9140

Email: loebm@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place