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

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Other: Control; Device: Masks; Device: Masks & hand hygiene

• Registration Number: NCT00833885
• Lead Sponsor: Robert Koch Institut

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-21
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Control	Control
2	Masks	Masks
3	Masks & hand hygiene	Masks and Hygiene

Primary Outcome Measures

Name	Time	Method
Secondary infection with influenza of the household members who are healthy at the start of the study

Trial Locations

Locations (1)

Robert Koch Institute; 🇩🇪 Berlin, Germany