Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

Brief Summary

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With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Control

Group Type OTHER

Control

Intervention Type OTHER

General information about virus transmission in households and basic means to prevent it

2

Masks

Group Type OTHER

Masks

Intervention Type DEVICE

Wearing of surgical masks

3

Masks and Hygiene

Group Type OTHER

Masks & hand hygiene

Intervention Type DEVICE

Wearing of surgical masks and intensified hand washing

Interventions

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Masks

Wearing of surgical masks

Intervention Type DEVICE

Masks & hand hygiene

Wearing of surgical masks and intensified hand washing

Intervention Type DEVICE

Control

General information about virus transmission in households and basic means to prevent it

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* influenza like illness symptoms
* positive rapid test for influenza
* inclusion within 48h of symptom onset
* inclusion of at least 3 members of a household (including index case)

Exclusion Criteria

* severe illness
* other cases of similar symptoms within 14 days before onset of symptoms in index patient
* severe asthma or COPD
* pregnancy of index

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No