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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833885
• Other study ID #: RKI-NPI
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: April 21, 2011
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Robert Koch Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Device:
• Masks
Wearing of surgical masks
• Masks & hand hygiene
Wearing of surgical masks and intensified hand washing

Other:
• Control
General information about virus transmission in households and basic means to prevent it

Locations

Country	Name	City	State
Germany	Robert Koch Institute	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Robert Koch Institut

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary infection with influenza of the household members who are healthy at the start of the study			No