Influenza Human Clinical Trial
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
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01034254 -
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|
Phase 3 | |
Terminated |
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N/A |