Clinical trial NCT00774774: Face Masks for Preventing Influenza Transmission
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza Human
Keywords: Influenza, human
Masks
Disease Transmission, Horizontal
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 372
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: during the study
Secondary outcomes:
measure: clinical events in all household members on the entire monitoring period (21 days).
timeFrame: 21 days
measure: Adverse events related to wearing a mask - a safety issue.
timeFrame: during the study
measure: Number of days of wearing a mask, number of masks used.
timeFrame: during the study
measure: Drug-consumption, in particular antibiotics
timeFrame: during the study
measure: Sick-leave from work (for adults contacts), or from school (for children of school age).
timeFrame: during the study
measure: Quality of life in the index patient.
timeFrame: during the study
measure: Infection with influenza virus at different time, among all household members.
timeFrame: during the study
measure: Quantification of viral load in patients infected.
timeFrame: during the study
measure: Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Fabrice CARRAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.