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

October 16, 2008
April 22, 2011
January 2009
September 2009   (final data collection date for primary outcome 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. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00774774 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Face Masks for Preventing Influenza Transmission
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza Human
  • Device: control
    Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
    Other Name: Control
  • 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
  • Placebo Comparator: 2
    No intervention
    Intervention: Device: control
  • Experimental: 1
    Mask
    Intervention: Device: Face mask

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
372
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00774774
P070160
No
laurent piazza, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Fabrice CARRAT, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP