Face Masks for Preventing Influenza Transmission

NCT ID: NCT00774774

Last Updated: 2011-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-09-30

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.

Conditions

Influenza Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2

No intervention

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: DEVICE

Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop

1

Mask

Group Type: EXPERIMENTAL

Face mask

Intervention Type: 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:

• 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

Interventions

control

Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop

Intervention Type: DEVICE

Face mask

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

Fabrice CARRAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Saint Antoine

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 13998 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21103330 (View on PubMed)

Other Identifiers

P070160

Identifier Type: -

Identifier Source: org_study_id