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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | No intervention |
|
| 1 | Experimental | Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control | Device | Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop |
| |
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Patient seeking medical advice for:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice CARRAT, MD PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Antoine | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13998 | Result | 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. | |
| 21103330 | Derived | 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. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| Face mask |
| Device |
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:
|
|
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |