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

This study has been completed.
Sponsor:
Information provided by:
Robert Koch Institut
ClinicalTrials.gov Identifier:
NCT00833885
First received: January 30, 2009
Last updated: April 21, 2011
Last verified: April 2011

January 30, 2009
April 21, 2011
January 2009
April 2011   (final data collection date for primary outcome measure)
Secondary infection with influenza of the household members who are healthy at the start of the study [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833885 on ClinicalTrials.gov Archive Site
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Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza

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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
  • Device: Masks
    Wearing of surgical masks
  • Device: 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
  • 1
    Control
    Intervention: Other: Control
  • 2
    Masks
    Intervention: Device: Masks
  • 3
    Masks and Hygiene
    Intervention: Device: Masks & hand hygiene
Suess T, Remschmidt C, Schink SB, Schweiger B, Nitsche A, Schroeder K, Doellinger J, Milde J, Haas W, Koehler I, Krause G, Buchholz U. The role of facemasks and hand hygiene in the prevention of influenza transmission in households: results from a cluster randomised trial; Berlin, Germany, 2009-2011. BMC Infect Dis. 2012 Jan 26;12:26. doi: 10.1186/1471-2334-12-26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00833885
RKI-NPI
No
Dr. med. Udo Buchholz, MPH, Robert Koch Institut
Robert Koch Institut
Not Provided
Not Provided
Robert Koch Institut
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP