A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410176
Recruitment Status : Unknown
Verified December 2006 by Ministry of Health, Israel.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2006
Last Update Posted : December 12, 2006
Information provided by:
Ministry of Health, Israel

Brief Summary:

The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated.

The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.

Condition or disease Intervention/treatment Phase
Influenza Behavioral: sanitation and personal hygiene Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Primary Outcome Measures :
  1. secondary infection of influenza within the family

Secondary Outcome Measures :
  1. compliance of non-pharmaceutical interventions

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
  • No limitations will be given regarding the number of family members.

Exclusion Criteria:

  • Presence of another household member with ILI during the previous two weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410176

Contact: Manfred S Green, PhD, M.D 972-3-7371500 ext 203

Sponsors and Collaborators
Ministry of Health, Israel
Principal Investigator: Manfred S Green, PhD, M.D ICDC Identifier: NCT00410176     History of Changes
Other Study ID Numbers: 4335CTIL
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: December 12, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases