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

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

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 Intervention
Influenza Device: Masks Device: Masks & hand hygiene Other: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Robert Koch Institut:

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

Estimated Enrollment: 300
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Other: Control
General information about virus transmission in households and basic means to prevent it
Device: Masks
Wearing of surgical masks
Masks and Hygiene
Device: Masks & hand hygiene
Wearing of surgical masks and intensified hand washing


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00833885

Robert Koch Institute
Berlin, Germany, 13353
Sponsors and Collaborators
Robert Koch Institut
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. med. Udo Buchholz, MPH, Robert Koch Institut Identifier: NCT00833885     History of Changes
Other Study ID Numbers: RKI-NPI
Study First Received: January 30, 2009
Last Updated: April 21, 2011

Keywords provided by Robert Koch Institut:
Non pharmaceutical measures

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on August 17, 2017