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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 372
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
2
No intervention
Intervention: control (Device)
1
Mask
Intervention: Face mask (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- 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)