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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
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

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 [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833885

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

No publications provided by Robert Koch Institut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. med. Udo Buchholz, MPH, Robert Koch Institut
ClinicalTrials.gov Identifier: NCT00833885     History of Changes
Other Study ID Numbers: RKI-NPI
Study First Received: January 30, 2009
Last Updated: April 21, 2011
Health Authority: Germany: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013