Face Masks for Preventing Influenza Transmission

Influenza Human Clinical Trial

— GRIPMASK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774774
• Other study ID #: P070160
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2008
• Last updated: April 22, 2011
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza Human
• Influenza, Human

Intervention

Device:
• control
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
• 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

Locations

Country	Name	City	State
France	Hopital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		during the study	Yes
Secondary	clinical events in all household members on the entire monitoring period (21 days).		21 days	Yes
Secondary	Adverse events related to wearing a mask - a safety issue.		during the study	Yes
Secondary	Number of days of wearing a mask, number of masks used.		during the study	Yes
Secondary	Drug-consumption, in particular antibiotics		during the study	Yes
Secondary	Sick-leave from work (for adults contacts), or from school (for children of school age).		during the study	Yes
Secondary	Quality of life in the index patient.		during the study	Yes
Secondary	Infection with influenza virus at different time, among all household members.		during the study	Yes
Secondary	Quantification of viral load in patients infected.		during the study	Yes
Secondary	Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).		during the study	Yes