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A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
This study is not yet open for participant recruitment.
Study NCT00410176   Information provided by Ministry of Health, Israel
First Received: December 11, 2006   No Changes Posted

December 11, 2006
December 11, 2006
January 2007
 
secondary infection of influenza within the family
Same as current
No Changes Posted
compliance of non-pharmaceutical interventions
Same as current
 
A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family
 

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%.

 
 
Interventional
Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Influenza
Behavioral: sanitation and personal hygiene
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
400
 
 

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.
Both
 
 
Contact: Manfred S Green, PhD, M.D 972-3-7371500 ext 203 m.green@icdc.health.gov.il
 
 
NCT00410176
 
4335CTIL
Ministry of Health, Israel
 
Principal Investigator: Manfred S Green, PhD, M.D ICDC
Ministry of Health, Israel
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP