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Completed

NCT Number: NCT00774774

Face Masks for Preventing Influenza Transmission

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Saint Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control

Device

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

face mask

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: GRIPMASK

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2008
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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