NCT00833885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

2.2 years

First QC Date

January 30, 2009

Last Update Submit

April 21, 2011

Conditions

Influenza

Keywords

Non pharmaceutical measures

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

1

OTHER

Control

Other: Control

2

OTHER

Masks

Device: Masks

3

OTHER

Masks and Hygiene

Device: Masks & hand hygiene

Interventions

MasksDEVICE

Wearing of surgical masks

2
Masks & hand hygieneDEVICE

Wearing of surgical masks and intensified hand washing

3
ControlOTHER

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

1

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • influenza like illness symptoms
  • positive rapid test for influenza

You may not qualify if:

  • severe illness
  • other cases of similar symptoms within 14 days before onset of symptoms in index patient
  • severe asthma or COPD
  • pregnancy of index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Koch Institute

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (3)

  • Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.

    PMID: 36715243DERIVED

  • 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.

    PMID: 33215698DERIVED

  • 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.

    PMID: 22280120DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

MasksHand Hygiene

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and AgricultureHygieneTherapeuticsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 2, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

DE(1)