Face Masks for Preventing Influenza Transmission (GRIPMASK)
Primary Purpose
Influenza Human
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
control
Face mask
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Human focused on measuring Influenza, human, Masks, Disease Transmission, Horizontal
Eligibility Criteria
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.
Sites / Locations
- Hopital Saint Antoine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
2
1
Arm Description
No intervention
Mask
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
clinical events in all household members on the entire monitoring period (21 days).
Adverse events related to wearing a mask - a safety issue.
Number of days of wearing a mask, number of masks used.
Drug-consumption, in particular antibiotics
Sick-leave from work (for adults contacts), or from school (for children of school age).
Quality of life in the index patient.
Infection with influenza virus at different time, among all household members.
Quantification of viral load in patients infected.
Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).
Full Information
NCT ID
NCT00774774
First Posted
October 16, 2008
Last Updated
April 22, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00774774
Brief Title
Face Masks for Preventing Influenza Transmission
Acronym
GRIPMASK
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Human
Keywords
Influenza, human, Masks, Disease Transmission, Horizontal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
No intervention
Arm Title
1
Arm Type
Experimental
Arm Description
Mask
Intervention Type
Device
Intervention Name(s)
control
Intervention Description
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
Intervention Type
Device
Intervention Name(s)
Face mask
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
during the study
Secondary Outcome Measure Information:
Title
clinical events in all household members on the entire monitoring period (21 days).
Time Frame
21 days
Title
Adverse events related to wearing a mask - a safety issue.
Time Frame
during the study
Title
Number of days of wearing a mask, number of masks used.
Time Frame
during the study
Title
Drug-consumption, in particular antibiotics
Time Frame
during the study
Title
Sick-leave from work (for adults contacts), or from school (for children of school age).
Time Frame
during the study
Title
Quality of life in the index patient.
Time Frame
during the study
Title
Infection with influenza virus at different time, among all household members.
Time Frame
during the study
Title
Quantification of viral load in patients infected.
Time Frame
during the study
Title
Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice CARRAT, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
13998
Citation
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.
Results Reference
result
PubMed Identifier
21103330
Citation
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.
Results Reference
derived
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Face Masks for Preventing Influenza Transmission
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