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Face Masks for Preventing Influenza Transmission (GRIPMASK)

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ClinicalTrials.gov Identifier: NCT00774774
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Human Device: control Device: Face mask Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 2
No intervention
 Device: control
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: September 2008

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases