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

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ClinicalTrials.gov Identifier: NCT00833885
Recruitment Status : Completed
First Posted : February 2, 2009
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
Robert Koch Institut

Study Description
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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.


Condition or disease Intervention/treatment Phase
Influenza Device: Masks Device: Masks & hand hygiene Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Study Start Date : January 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
1
Control
 Other: Control
General information about virus transmission in households and basic means to prevent it
2
Masks
 Device: Masks
Wearing of surgical masks
3
Masks and Hygiene
 Device: Masks & hand hygiene
Wearing of surgical masks and intensified hand washing


Outcome Measures
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Primary Outcome Measures :
  1. Secondary infection with influenza of the household members who are healthy at the start of the study

Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833885


Locations
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Germany
Robert Koch Institute
Berlin, Germany, 13353
Sponsors and Collaborators
Robert Koch Institut
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. med. Udo Buchholz, MPH, Robert Koch Institut
ClinicalTrials.gov Identifier: NCT00833885    
Other Study ID Numbers: RKI-NPI
First Posted: February 2, 2009    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: April 2011
Keywords provided by Robert Koch Institut:
Non pharmaceutical measures
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases