Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Masks
Masks & hand hygiene
Control
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Non pharmaceutical measures
Eligibility 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
Sites / Locations
- Robert Koch Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
1
2
3
Arm Description
Control
Masks
Masks and Hygiene
Outcomes
Primary Outcome Measures
Secondary infection with influenza of the household members who are healthy at the start of the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00833885
Brief Title
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Official Title
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Robert Koch Institut
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Non pharmaceutical measures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Control
Arm Title
2
Arm Type
Other
Arm Description
Masks
Arm Title
3
Arm Type
Other
Arm Description
Masks and Hygiene
Intervention Type
Device
Intervention Name(s)
Masks
Intervention Description
Wearing of surgical masks
Intervention Type
Device
Intervention Name(s)
Masks & hand hygiene
Intervention Description
Wearing of surgical masks and intensified hand washing
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
General information about virus transmission in households and basic means to prevent it
Primary Outcome Measure Information:
Title
Secondary infection with influenza of the household members who are healthy at the start of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Robert Koch Institute
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33215698
Citation
Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
Results Reference
derived
PubMed Identifier
22280120
Citation
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.
Results Reference
derived
Learn more about this trial
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
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