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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00833885
Enrollment
300
Registered
2009-02-02
Start date
2009-01-31
Completion date
2011-04-30
Last updated
2011-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Non pharmaceutical measures

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.

Interventions

DEVICEMasks

Wearing of surgical masks

DEVICEMasks & hand hygiene

Wearing of surgical masks and intensified hand washing

OTHERControl

General information about virus transmission in households and basic means to prevent it

Sponsors

Robert Koch Institut
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Secondary infection with influenza of the household members who are healthy at the start of the study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026