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Face Masks for Preventing Influenza Transmission (GRIPMASK)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00774774
First received: October 16, 2008
Last updated: April 22, 2011
Last verified: September 2008
History of Changes
  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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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 ]
Enrollment: 372
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
No intervention
 Device: control
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
Other Name: Control
Experimental: 1
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
Other Name: Face mask

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: laurent piazza, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00774774     History of Changes
Other Study ID Numbers: P070160
Study First Received: October 16, 2008
Last Updated: April 22, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Influenza, human
Masks
Disease Transmission, Horizontal

ClinicalTrials.gov processed this record on March 03, 2015