Face Masks for Preventing Influenza Transmission - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00774774

Purpose

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.

Condition	Intervention	Phase
Influenza Human	Device: control Device: Face mask	Phase IV

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	372
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator No intervention	Device: control Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
1: Experimental Mask	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

Arms

Assigned Interventions

2: Placebo Comparator

No intervention

Device: control

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

1: Experimental

Mask

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

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

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774774

Contacts

Contact: Fabrice CARRAT, MD PhD

+33(0)1 44 73 84 58

carrat@u707.jussieu.fr

Locations

France
Hopital Saint Antoine
PARIS, France, 75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Fabrice CARRAT, MD PhD

Assistance Publique - Hôpitaux de Paris

More Information

GRIPMASK

This link exits the ClinicalTrials.gov site

Responsible Party:	Department Clinical Research of Developpement ( Magali LAFAYE )
Study ID Numbers:	P070160, IDRCB 2008-A00433-52
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00774774
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Influenza, human
Masks
Disease Transmission, Horizontal

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Facies

Neoplasm Metastasis
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009