A Phase 4 interventional study of control and Face mask in Influenza Human, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2011-04-26.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 372 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient seeking medical advice for:
Exclusion Criteria:
No intervention
Device: control
Mask
Device: Face mask
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
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
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris