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

Robert Koch Institut

Status: Completed

Conditions: Influenza

Treatments: Device: Masks; Device: Masks & hand hygiene; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00833885

RKI-NPI

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 3 patient groups

1

Other group

Description:

Control

Treatment:

Other: Control

2

Other group

Description:

Masks

Treatment:

Device: Masks

3

Other group

Description:

Masks and Hygiene

Treatment:

Device: Masks & hand hygiene