Face Masks for Preventing Influenza Transmission (GRIPMASK)

a Randomized Controlled Trial Evaluating the Effectiveness and the Safety of Surgical Masks Wared by the Index Patient for Preventing Secondary Transmission of Influenza A in Households

This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household.

Study Overview

• Status: Completed
• Conditions: Influenza Human
• Intervention / Treatment: Device: control; Device: Face mask

Detailed Description

Background. Non pharmaceutical interventions, and in particular the wearing of face masks, could play a role in controlling the transmission of influenza in the early stages of the epidemic. In the French pandemic plan, surgical masks are recommended in contagious patients in wards. The effectiveness of such masks in preventing transmission of influenza A virus is unknown. Our project aims to assess the preventive efficacy and tolerance of surgical mask.

The primary objective is to measure the decrease of the number of secondary cases of flu in households where the index case will wear a surgical mask during its period of infectiousness (5 days), compared to households where the index case will not be subject to this intervention. Secondary objectives are: (1) to study the feasibility and tolerance of wearing a mask continuously during the period of viral shedding; (2) virological description of infection spreading among household contacts based on virological collections.

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hopital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient seeking medical advice for:

• For symptoms less than 48 hours, combining fever> = 37.8 ° C and a cough,
• during the period of a seasonal influenza epidemic (as defined by the Sentinel network)
• Older than 5 years
• And living in a household size between 3 to 8..
• The patient is the first case in the household (index patient). The patient has a positive rapid influenza A test.
• Informed consent.
• Affiliation to the social security.

Exclusion Criteria:

• When concomitant influenza cases are known in other householders
• When the patient is suffering from asthma or COPD (ongoing treatment):
• Hospitalization.
• Treatment by a neuraminidase inhibitor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; No intervention	Device: control; Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
EXPERIMENTAL: 1; Mask	Device: Face mask; Non sterile surgical mask, high filtration "AEROKYN", type 2 with eardrop Masks will be worn at home by the patient over a period of 5 days following inclusion, whenever a member of the household will attend the same room or in other confined space (eg car), and changed after 3 hours of consecutive use or sooner if they are tor Masks will not be worn: during the night,; when the patient is alone in the room. Moreover, for all households, an incentive in nocturnal isolation of index-patient will be recommended

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat.	during the study

Secondary Outcome Measures

Outcome Measure	Time Frame
clinical events in all household members on the entire monitoring period (21 days).	21 days
Adverse events related to wearing a mask - a safety issue.	during the study
Number of days of wearing a mask, number of masks used.	during the study
Drug-consumption, in particular antibiotics	during the study
Sick-leave from work (for adults contacts), or from school (for children of school age).	during the study
Quality of life in the index patient.	during the study
Infection with influenza virus at different time, among all household members.	during the study
Quantification of viral load in patients infected.	during the study
Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).	during the study

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Fabrice CARRAT, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Sies H, Akerboom TP, Tager JM. Mitochondrial and cytosolic NADPH systems and isocitrate dehydrogenase indicator metabolites during ureogensis from ammonia in isolated rat hepatocytes. Eur J Biochem. 1977 Jan;72(2):301-7. doi: 10.1111/j.1432-1033.1977.tb11253.x.
• Canini L, Andreoletti L, Ferrari P, D'Angelo R, Blanchon T, Lemaitre M, Filleul L, Ferry JP, Desmaizieres M, Smadja S, Valleron AJ, Carrat F. Surgical mask to prevent influenza transmission in households: a cluster randomized trial. PLoS One. 2010 Nov 17;5(11):e13998. doi: 10.1371/journal.pone.0013998.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (ESTIMATE): October 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 22, 2011
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Masks; Influenza, human; Disease Transmission, Horizontal
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: P070160