NCT00774774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 26, 2011

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

October 16, 2008

Last Update Submit

April 22, 2011

Conditions

Influenza Human

Keywords

Influenza, humanMasksDisease Transmission, Horizontal

Outcome Measures

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.

    during the study

Secondary Outcomes (9)

  • clinical events in all household members on the entire monitoring period (21 days).

    21 days

  • Adverse events related to wearing a mask - a safety issue.

    during the study

  • Number of days of wearing a mask, number of masks used.

    during the study

  • Drug-consumption, in particular antibiotics

    during the study

  • Sick-leave from work (for adults contacts), or from school (for children of school age).

    during the study

  • +4 more secondary outcomes

Study Arms (2)

2

PLACEBO COMPARATOR

No intervention

Device: control

1

EXPERIMENTAL

Mask

Device: Face mask

Interventions

controlDEVICE

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

2
Face maskDEVICE

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

1

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Antoine

Paris, 75012, France

Location

Related Publications (2)

  • Sies H, Akerboom TP, Tager JM. Mitochondrial and cytosolic NADPH systems and isocitrate dehydrogenase indicator metabolites during ureogensis from ammonia in isolated rat hepatocytes. Eur J Biochem. 1977 Jan;72(2):301-7. doi: 10.1111/j.1432-1033.1977.tb11253.x.

    PMID: 13998RESULT

  • Canini L, Andreoletti L, Ferrari P, D'Angelo R, Blanchon T, Lemaitre M, Filleul L, Ferry JP, Desmaizieres M, Smadja S, Valleron AJ, Carrat F. Surgical mask to prevent influenza transmission in households: a cluster randomized trial. PLoS One. 2010 Nov 17;5(11):e13998. doi: 10.1371/journal.pone.0013998.

    PMID: 21103330DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Fabrice CARRAT, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 26, 2011

Record last verified: 2008-09

Locations

FR(1)