Face Masks for Preventing Influenza Transmission (GRIPMASK)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00774774 |
Recruitment Status :
Completed
First Posted : October 17, 2008
Last Update Posted : April 26, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Human | Device: control Device: Face mask | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 372 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 Start Date : | January 2009 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774774
France | |
Hopital Saint Antoine | |
Paris, France, 75012 |
Principal Investigator: | Fabrice CARRAT, MD PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | laurent piazza, Department Clinical Research of Developpement |
ClinicalTrials.gov Identifier: | NCT00774774 |
Other Study ID Numbers: |
P070160 |
First Posted: | October 17, 2008 Key Record Dates |
Last Update Posted: | April 26, 2011 |
Last Verified: | September 2008 |
Influenza, human Masks Disease Transmission, Horizontal |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |