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Face Masks for Preventing Influenza Transmission (GRIPMASK)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Influenza Human | Device: control Device: Face mask | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
- 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 ]
| Enrollment: | 372 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00774774
| France | |
| Hopital Saint Antoine | |
| Paris, France, 75012 | |
| Principal Investigator: | Fabrice CARRAT, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
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 History of Changes |
| Other Study ID Numbers: |
P070160 |
| Study First Received: | October 16, 2008 |
| Last Updated: | April 22, 2011 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Influenza, human Masks Disease Transmission, Horizontal |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 23, 2017